Brufanic

Brufanic may be available in the countries listed below.

Ingredient matches for Brufanic

Ibuprofen

Ibuprofen is reported as an ingredient of Brufanic in the following countries:

• Japan

International Drug Name Search

Rogaine Solution

Pronunciation: mi-NOX-i-dil
Generic Name: Minoxidil
Brand Name: Rogaine

Rogaine Solution is used for:

Promoting hair regrowth in patients who are experiencing gradually thinning hair or gradual hair loss on the top of the head.

Rogaine Solution is a vasodilator. It is not known how Rogaine Solution stimulates scalp hair growth. It is possible that it dilates blood vessels in the scalp, which may improve hair follicle function and stimulate scalp hair growth.

Do NOT use Rogaine Solution if:

• you are allergic to any ingredient in Rogaine Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rogaine Solution:

Some medical conditions may interact with Rogaine Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart or blood pressure problems

Some MEDICINES MAY INTERACT with Rogaine Solution. Because little, if any, of Rogaine Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Rogaine Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rogaine Solution:

Use Rogaine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Before use, wash your scalp with a mild shampoo. Your hair and scalp must be dry before applying Rogaine Solution. Wash your hands after applying Rogaine Solution. Allow the solution to remain on the scalp for at least 4 hours before washing. Wait approximately 4 hours after application before going swimming, and do not allow your scalp to get wet from the rain after applying the solution.


• Wait until the solution is dry before using other hair care products.


• If you miss a dose of Rogaine Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Rogaine Solution.

Important safety information:

• Rogaine Solution is for topical use only. Avoid getting Rogaine Solution in your eyes, nose, or mouth. If you get Rogaine Solution in your eyes, wash them out with cool tap water.


• Rogaine Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rogaine Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not use with other medicines or ointments on the scalp.


• Temporary hair loss may continue for up to 2 weeks after you start using Rogaine Solution. Contact your doctor if you continue to lose hair after 2 weeks.


• Several months may pass before you see improvement. If you do not see improvement after 4 months, check with your doctor.


• Do not use on scalp that is irritated or sunburned.


• Rogaine Solution will not improve hair loss caused by grooming methods (eg, ponytails, braiding) or the use of other hair care products that cause scarring or deep burns on the scalp.


• Rogaine Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Rogaine Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rogaine Solution while you are pregnant. It is not known if Rogaine Solution is found in breast milk. Do not breast-feed while using Rogaine Solution.

Possible side effects of Rogaine Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or irritation of the eye; itching; redness or irritation at the treated area; unwanted hair growth elsewhere on the body.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dizziness; fainting; fast heartbeat; sudden, unexplained weight gain; swollen hands or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Rogaine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Rogaine Solution may be harmful if swallowed.

Proper storage of Rogaine Solution:

Store Rogaine Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat and light. Keep Rogaine Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Rogaine Solution, please talk with your doctor, pharmacist, or other health care provider.


• Rogaine Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Rogaine Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Rogaine resources

• Rogaine Side Effects (in more detail)
• Rogaine Use in Pregnancy & Breastfeeding
• Rogaine Drug Interactions
• Rogaine Support Group
• 3 Reviews for Rogaine - Add your own review/rating

Compare Rogaine with other medications

• Alopecia

Vicrom

Vicrom may be available in the countries listed below.

Ingredient matches for Vicrom

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Vicrom in the following countries:

• Israel


• New Zealand

International Drug Name Search

Midazolam Anesfarma

Midazolam Anesfarma may be available in the countries listed below.

Ingredient matches for Midazolam Anesfarma

Midazolam

Midazolam is reported as an ingredient of Midazolam Anesfarma in the following countries:

• Spain

International Drug Name Search

Rinofrenal Plus

Rinofrenal Plus may be available in the countries listed below.

Ingredient matches for Rinofrenal Plus

Chlorphenamine

Chlorphenamine maleate (a derivative of Chlorphenamine) is reported as an ingredient of Rinofrenal Plus in the following countries:

• Spain

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Rinofrenal Plus in the following countries:

• Spain

International Drug Name Search

Osmorol

Osmorol may be available in the countries listed below.

Ingredient matches for Osmorol

Mannitol

Mannitol is reported as an ingredient of Osmorol in the following countries:

• Peru

International Drug Name Search

Heparin-Rotexmedica

Heparin-Rotexmedica may be available in the countries listed below.

Ingredient matches for Heparin-Rotexmedica

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparin-Rotexmedica in the following countries:

• Germany

International Drug Name Search

Durasal

salicylic acid

Dosage Form: topical solution

Package Insert Durasal

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION

Durasal™ is a topical preparation for treatment of common and plantar warts containing 26% salicylic acid in a film-forming vehicle composed of isopropyl alcohol, butyl acetate, polyvinyl butyral, trimethyl pentanyl diisobutyrate and acrylates copolymer. The pharmacologic activity of Durasal is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is:

CLINICAL PHARMACOLOGY

Although the exact mode of action of salicylic acid in the treatment of warts is not known, its activity appears to be associated with its keratolytic action which results in mechanical removal of epidermal cells infected with wart viruses.

INDICATIONS AND USAGE

Durasal is indicated for the topical treatment and removal of common warts and plantar warts.

CONTRAINDICATIONS

Durasal should not be used by diabetics or patients with impaired blood circulation. Durasal should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.

PRECAUTIONS

Durasal is for external use only. Do not permit Durasal to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Durasal should not be allowed to contact normal skin surrounding wart. Treatment should be discontinued if excessive irritation occurs. Durasal is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use.

ADVERSE REACTIONS

A localized irritant reaction may occur if Durasal is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.

DOSAGE AND ADMINISTRATION

Prior to application of Durasal, soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth or emery board. Dry thoroughly. Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Treatment should be once or twice a day and should continue as directed by physician. Be careful not to apply to surrounding skin. Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of drug use.

HOW SUPPLIED

Durasal is supplied in 10ml amber bottles with a brush applicator (NDC 42783-301-10).

Store at controlled room temperature, 15° to 30°C (59° to 86°F).

Manufactured for:

Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent Pending

6/2009

Durasal (Salicylic Acid, 26%) Wart Remover 10 mL Container Label Principal Display Panel Text:

NDC 42783-301-10

Durasal

solution, 26%

10 mL

FOR TOPICAL USE ONLY

NOT FOR USE IN THE EYES

Rx only

Durasal (Salicylic Acid, 26%) Wart Remover 10 mL Carton Label Principal Display Panel Text:

NDC 42783-301-10

Durasal

solution, 26%

10 mL

FOR TOPICAL USE ONLY

NOT FOR USE IN THE EYES

Rx only

Durasal  salicylic acid  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42783-301 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength salicylic acid (salicylic acid) salicylic acid 260 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42783-301-10 1 BOTTLE In 1 CARTON contains a BOTTLE, WITH APPLICATOR 1 10 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (42783-301-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/03/2009

Labeler - Elorac, Inc. (832590009)

Registrant - Elorac, Inc. (832590009)

Establishment
Name	Address	ID/FEI	Operations
Harmony Labs		105803274	manufacture

Revised: 02/2010Elorac, Inc.

More Durasal resources

• Durasal Use in Pregnancy & Breastfeeding
• Durasal Drug Interactions
• Durasal Support Group
• 0 Reviews for Durasal - Add your own review/rating

• Durasal Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Compound W Concise Consumer Information (Cerner Multum)


• Duofilm Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Duoplant Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Freezone Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrisalic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Ionil Plus Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Keralyt Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Keralyt Scalp Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Salacyn Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Salex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Salkera Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Virasal Film-Forming Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Durasal with other medications

• Acne
• Dermatological Disorders
• Warts

Amlodipine Alter

Amlodipine Alter may be available in the countries listed below.

Ingredient matches for Amlodipine Alter

Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipine Alter in the following countries:

• France

International Drug Name Search

Marvil

Marvil may be available in the countries listed below.

Ingredient matches for Marvil

Alendronic Acid

Alendronic Acid is reported as an ingredient of Marvil in the following countries:

• Argentina


• Peru

International Drug Name Search

Tussamed

Tussamed may be available in the countries listed below.

Ingredient matches for Tussamed

Clobutinol

Clobutinol hydrochloride (a derivative of Clobutinol) is reported as an ingredient of Tussamed in the following countries:

• Romania

International Drug Name Search

Pan

Pan may be available in the countries listed below.

Ingredient matches for Pan

Pantoprazole

Pantoprazole is reported as an ingredient of Pan in the following countries:

• India

International Drug Name Search

Totifen

Totifen may be available in the countries listed below.

Ingredient matches for Totifen

Ketotifen

Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Totifen in the following countries:

• Greece

International Drug Name Search

Dihydroergocristine

Scheme

BAN

ATC (Anatomical Therapeutic Chemical Classification)

C04AE04

CAS registry number (Chemical Abstracts Service)

0017479-19-5

Chemical Formula

C35-H41-N5-O5

Molecular Weight

611

Therapeutic Category

Vasodilator, peripheric

Chemical Name

Ergotaman-3',6',18-trione, 9,10-dihydro-12'-hydroxy-2'-(1-methylethyl)-5'-(phenylmethyl)-, (5'α,10α)-

Foreign Names

• Dihydroergocristin (German)
• Dihydroergocristine (French)

Generic Names

• Dihydroergocristine (OS: DCF, BAN)
• DF 69 (IS)
• Dihydroergocristine Mesilate (OS: BAN)
• Dihydroergocristine methanesulfonate (IS)
• Dihydroergocristine (mésilate de) (PH: Ph. Eur. 6)
• Dihydroergocristine Mesilate (PH: BP 2010, Ph. Eur. 6)
• Dihydroergocristini mesilas (PH: Ph. Eur. 6)
• Dihydroergocristinmesilat (PH: Ph. Eur. 6)

Brand Names

• Brinerdin (Dihydroergocristine and Clopamide, + Reserpine)
  Krka, Slovenia; Novartis, South Africa



• Agiobita
  S.J.A., Greece



• Almirid
  Polichem, Czech Republic



• Anavenol
  Zentiva, Georgia



• Beytina
  Leovan, Greece



• Brinerdin (Dihydroergocristine and Clopamide, + Reserpine)
  Novartis, Bahrain; Novartis, Switzerland; Novartis, Oman



• Clinadil (Dihydroergocristine and Cinnarizine)
  Stada, Spain



• Crystepin
  Zentiva, Georgia



• Diemil (Dihydroergocristine and Piracetam)
  Almirall, Spain



• Diertina
  Pharmanel, Greece; Sankyo, Portugal



• Diertine
  Astellas, Spain



• Ergodavur
  Davur, Spain



• Ergofil
  Vocate, Greece



• Ersilan (Dihydroergocristine and Etofylline)
  Ivax, Slovakia



• Fenitina
  Leovan, Greece



• Hydergine
  Novartis, Hong Kong



• Iskédyl (Dihydroergocristine and Raubasine)
  Pierre Fabre Médicament, France



• Iskemil
  Aché, Brazil



• Memotil
  Genepharm, Greece



• Nehydrin
  Sanochemia, Austria



• Vasobral
  CNW, Hong Kong

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Albipenal

Albipenal may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Albipenal

Ampicillin

Ampicillin is reported as an ingredient of Albipenal in the following countries:

• Austria

International Drug Name Search

Pentoxifylline-Teva

Pentoxifylline-Teva may be available in the countries listed below.

Ingredient matches for Pentoxifylline-Teva

Pentoxifylline

Pentoxifylline is reported as an ingredient of Pentoxifylline-Teva in the following countries:

• France


• Israel

International Drug Name Search

Laxose

Laxose may be available in the countries listed below.

Ingredient matches for Laxose

Lactulose

Lactulose is reported as an ingredient of Laxose in the following countries:

• Ireland

International Drug Name Search

Retin-A Cream, Gel, Liquid

Dosage Form: Cream, Gel, Liquid

For Topical Use Only

Description

RETIN-A Gel, Cream and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. RETIN-A (tretinoin) Cream contains tretinoin in either of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. RETIN-A Liquid contains tretinoin 0.05% by weight, polyethylene glycol 400, butylated hydroxytoluene and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 55%. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:

Clinical Pharmacology

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Indications and Usage

RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

Contraindications

Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

Precautions

General: If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.

RETIN-A (tretinoin) acne treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with RETIN-A. It also is advisable to “rest” a patient's skin until the effects of such preparations subside before use of RETIN-A is begun.

Carcinogenesis: Long-term animal studies to determine the carcinogenic potential of tretinoin have not been performed. Studies in hairless albino mice suggest that tretinoin may accelerate the tumorigenic potential of weakly carcinogenic light from a solar simulator. In other studies, when lightly pigmented hairless mice treated with tretinoin were exposed to carcinogenic doses of UVB light, the incidence and rate of development of skin tumors was reduced. Due to significantly different experimental conditions, no strict comparison of these disparate data is possible. Although the significance of these studies to man is not clear, patients should avoid or minimize exposure to sun.

Pregnancy: Teratogenic effects. Pregnancy Category C. Oral tretinoin has been shown to be teratogenic in rats when given in doses 1000 times the topical human dose. Oral tretinoin has been shown to be fetotoxic in rats when given in doses 500 times the topical human dose.

Topical tretinoin has not been shown to be teratogenic in rats and rabbits when given in doses of 100 and 320 times the topical human dose, respectively (assuming a 50 kg adult applies 250 mg of 0.1% cream topically). However, at these topical doses, delayed ossification of a number of bones occurred in both species. These changes may be considered variants of normal development and are usually corrected after weaning. There are no adequate and well-controlled studies in pregnant women. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RETIN-A is administered to a nursing woman.

GELS ARE FLAMMABLE. Note: Keep away from heat and flame. Keep tube tightly closed.

Adverse Reactions

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper or hypopigmentation has been reported with repeated application of RETIN-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with RETIN-A. To date, all adverse effects of RETIN-A have been reversible upon discontinuance of therapy (see Dosage and Administration Section).

Overdosage

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

Dosage and Administration

RETIN-A Gel, Cream or Liquid should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Liquid: The liquid may be applied using a fingertip, gauze pad, or cotton swab. If gauze or cotton is employed, care should be taken not to oversaturate it to the extent that the liquid would run into areas where treatment is not intended. Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of over application by the patient.

Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.

Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.

During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.

Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.

Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.

Patients treated with RETIN-A (tretinoin) acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (See Precautions.)

How Supplied

RETIN-A (tretinoin) is supplied as:

RETIN-A Cream			RETIN-A Gel			RETIN-A Liquid
	RETIN-A	RETIN-A		RETIN-A	RETIN-A		RETIN-A	RETIN-A
NDC Code	Strength/Form	Qty.	NDC Code	Strength/Form	Qty.	NDC Code	Strength/Form	Qty.
0062-0165-01	0.025%	Cream 20g	0062-0575-44	0.01%	Gel 15g	0062-0075-07	0.05% Liquid	28mL
0062-0165-02	0.025%	Cream 45g	0062-0575-46	0.01%	Gel 45g
0062-0175-12	0.05%	Cream 20g	0062-0475-42	0.025%	Gel 15g
0062-0175-13	0.05%	Cream 45g	0062-0475-45	0.025%	Gel 45g
0062-0275-23	0.1%	Cream 20g
0062-0275-01	0.1%	Cream 45g

Storage Conditions: RETIN-A Liquid, 0.05%, and RETIN-A Gel, 0.025% and 0.01%: store below 86°F. RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.

ORTHO DERMATOLOGICAL

Division of Ortho-McNeil

Pharmaceutical, Inc.

Skillman, New Jersey 08558

©OMP 2001 Revised February 2001 Printed in U.S.A. 643-10-490-9

PATIENT INSTRUCTIONS

Retin-A®

(tretinoin)

Acne Treatment

IMPORTANT

Read Directions Carefully Before Using

Cream · Gel · Liquid

For Topical Use Only

THIS LEAFLET TELLS YOU ABOUT RETIN-A (TRETINOIN) ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR'S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE LONG-TERM SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR.

WARNINGS AND PRECAUTIONS

The effects of the sun on your skin. As you know, overexposure to natural sunlight or the artificial sunlight of a sunlamp can cause sunburn. Overexposure to the sun over many years may cause premature aging of the skin and even skin cancer. The chance of these effects occurring will vary depending on skin type, the climate and the care taken to avoid overexposure to the sun. Therapy with RETIN-A may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized.

Laboratory findings.When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient in RETIN-A, tretinoin. In some studies, under different conditions, however, when mice treated with tretinoin were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that tretinoin alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing.

Use caution in the sun. When outside, even on hazy days, areas treated with RETIN-A should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection). For extended sun exposure, protective clothing, like a hat, should be worn. Do not use artificial sunlamps while you are using RETIN-A. If you do become sunburned, stop your therapy with RETIN-A until your skin has recovered.

Avoid excessive exposure to wind or cold. Extremes of climate tend to dry or burn normal skin. Skin treated with RETIN-A may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.

Possible problems. The skin of certain sensitive individuals may become excessively red, swollen, blistered or crusted. If you are experiencing severe or persistent irritation, discontinue the use of RETIN-A and consult your physician.

There have been reports that, in some patients, areas treated with RETIN-A developed a temporary increase or decrease in the amount of skin pigment (color) present. The pigment in these areas returned to normal either when the skin was allowed to adjust to RETIN-A or therapy was discontinued.

Use other medication only on your physician's advice. Only your physician knows which other medications may be helpful during treatment and will recommend them to you if necessary. Follow the physician's instructions carefully. In addition, you should avoid preparations that may dry or irritate your skin. These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos and hair permanent solutions. Do not allow anyone else to use this medication.

Do not use other medications with RETIN-A which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling.

If you are pregnant, think you are pregnant or are nursing an infant: No studies have been conducted in humans to establish the safety of RETIN-A in pregnant women. If you are pregnant, think you are pregnant, or are nursing a baby, consult your physician before using this medication.

GELS ARE FLAMMABLE. Note: Keep away from heat and flame. Keep tube tightly closed.

AND WHILE YOU'RE ON RETIN-A THERAPY

Use a mild, non-medicated soap. Avoid frequent washings and harsh scrubbing. Acne isn't caused by dirt, so no matter how hard you scrub, you can't wash it away. Washing too frequently or scrubbing too roughly may at times actually make your acne worse. Wash your skin gently with a mild, bland soap. Two or three times a day should be sufficient. Pat skin dry with a towel. Let the face dry 20 to 30 minutes before applying RETIN-A. Remember, excessive irritation such as rubbing, too much washing, use of other medications not suggested by your physician, etc., may worsen your acne.

HOW TO USE RETIN-A (TRETINOIN)

To get the best results with RETIN-A therapy, it is necessary to use it properly. Forget about the instructions given for other products and the advice of friends. Just stick to the special plan your doctor has laid out for you and be patient. Remember, when RETIN-A is used properly, many users see improvement by 12 weeks. AGAIN, FOLLOW INSTRUCTIONS – BE PATIENT – DON'T START AND STOP THERAPY ON YOUR OWN – IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR.

To help you use the medication correctly, keep these simple instructions in mind.

• Apply RETIN-A once daily before bedtime, or as directed by your physician. Your physician may advise, especially if your skin is sensitive, that you start your therapy by applying RETIN-A every other night. First, wash with a mild soap and dry your skin gently.WAIT 20 to 30 MINUTES BEFORE APPLYING MEDICATION; it is important for skin to be completely dry in order to minimize possible irritation.


• It is better not to use more than the amount suggested by your physician or to apply more frequently than instructed.Too much may irritate the skin, waste medication and won't give faster or better results.


• Keep the medication away from the corners of the nose, mouth, eyes and open wounds. Spread away from these areas when applying.


• Cream: Squeeze about a half inch or less of medication onto the fingertip. While that should be enough for your whole face, after you have some experience with the medication you may find you need slightly more or less to do the job. The medication should become invisible almost immediately. If it is still visible, you are using too much. Cover the affected area lightly with RETIN-A (tretinoin) Cream by first dabbing it on your forehead, chin and both cheeks, then spreading it over the entire affected area. Smooth gently into the skin.


• Gel: Squeeze about a half inch or less of medication onto the fingertip. While that should be enough for your whole face, after you have some experience with the medication you may find you need slightly more or less to do the job. The medication should become invisible almost immediately. If it is still visible, or if dry flaking occurs from the gel within a minute or so, you are using too much. Cover the affected area lightly with RETIN-A (tretinoin) Gel by first dabbing it on your forehead, chin and both cheeks, then spreading it over the entire affected area. Smooth gently into the skin.


• Liquid: RETIN-A (tretinoin) Liquid may be applied to the skin where acne lesions appear, spreading the medication over the entire affected area, using a fingertip, gauze pad, or cotton swab. If gauze or cotton is employed, care should be taken not to oversaturate it to the extent that the liquid would run into areas where treatment is not intended (such as corners of the mouth, eyes, and nose).


• It is recommended that you apply a moisturizer or a moisturizer with sunscreen that will not aggravate your acne (noncomedogenic) every morning after you wash.

WHAT TO EXPECT WITH YOUR NEW TREATMENT

RETIN-A works deep inside your skin and this takes time. You cannot make RETIN-A work any faster by applying more than one dose each day, but an excess amount of RETIN-A may irritate your skin. Be patient.

There may be some discomfort or peeling during the early days of treatment. Some patients also notice that their skin begins to take on a blush.

These reactions do not happen to everyone. If they do, it is just your skin adjusting to RETIN-A and this usually subsides within two to four weeks. These reactions can usually be minimized by following instructions carefully. Should the effects become excessively troublesome, consult your doctor.

BY THREE TO SIX WEEKS, some patients notice an appearance of new blemishes (papules and pustules). At this stage it is important to continue using RETIN-A.

If RETIN-A is going to have a beneficial effect for you, you should notice a continued improvement in your appearance after 6 to 12 weeks of therapy. Don't be discouraged if you see no immediate improvement. Don't stop treatment at the first signs of improvement.

Once your acne is under control you should continue regular application of RETIN-A until your physician instructs otherwise.

IF YOU HAVE QUESTIONS

All questions of a medical nature should be taken up with your doctor. For more information about RETIN-A (tretinoin), call our toll-free number: 800-426-7762. Call between 9:00 a.m. and 3:00 p.m. Eastern Time, Monday through Friday.

ORTHO DERMATOLOGICAL

Division of Ortho-McNeil

Pharmaceutical, Inc.

Skillman, New Jersey 08558

©OMP 2001 Revised February 2001 Printed in U.S.A. 643-10-490-9

RETIN-A  tretinoin  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0062-0165 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tretinoin (Tretinoin) Active 0.25 MILLIGRAM  In 1 GRAM stearic acid Inactive   isopropyl myristate Inactive   polyoxyl 40 stearate Inactive   stearyl alcohol Inactive   xanthan gum Inactive   sorbic acid Inactive   butylated hydroxytoluene Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0062-0165-01 20 g (GRAM) In 1 TUBE None 2 0062-0165-02 45 g (GRAM) In 1 TUBE None

RETIN-A  tretinoin  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0062-0275 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tretinoin (Tretinoin) Active 1 MILLIGRAM  In 1 GRAM stearic acid Inactive   isopropyl myristate Inactive   polyoxyl 40 stearate Inactive   stearyl alcohol Inactive   xanthan gum Inactive   sorbic acid Inactive   butylated hydroxytoluene Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0062-0275-23 20 g (GRAM) In 1 TUBE None 2 0062-0275-01 45 g (GRAM) In 1 TUBE None

RETIN-A  tretinoin  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0062-0175 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tretinoin (Tretinoin) Active 0.5 MILLIGRAM  In 1 GRAM stearic acid Inactive   isopropyl myristate Inactive   polyoxyl 40 stearate Inactive   stearyl alcohol Inactive   xanthan gum Inactive   sorbic acid Inactive   butylated hydroxytoluene Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0062-0175-12 20 g (GRAM) In 1 TUBE None 2 0062-0175-13 45 g (GRAM) In 1 TUBE None

RETIN-A  tretinoin  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0062-0475 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tretinoin (Tretinoin) Active 0.25 MILLIGRAM  In 1 GRAM butylated hydroxytoluene Inactive   hydroxypropyl cellulose Inactive   alcohol Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0062-0475-42 15 g (GRAM) In 1 TUBE None 2 0062-0475-45 45 g (GRAM) In 1 TUBE None

RETIN-A  tretinoin  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0062-0575 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tretinoin (Tretinoin) Active 0.1 MILLIGRAM  In 1 GRAM butylated hydroxytoluene Inactive   hydroxypropyl cellulose Inactive   alcohol Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0062-0575-44 15 g (GRAM) In 1 TUBE None 2 0062-0575-46 45 g (GRAM) In 1 TUBE None

RETIN-A  tretinoin  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0062-0075 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Tretinoin (Tretinoin) Active 0.5 MILLIGRAM  In 1 MILLILITER polyethylene glycol 400 Inactive   butylated hydroxytoluene Inactive   alcohol Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0062-0075-42 28 mL (MILLILITER) In 1 BOTTLE None

Revised: 04/2007ORTHO DERMATOLOGICAL

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Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

L01CD01

CAS registry number (Chemical Abstracts Service)

0033069-62-4

Chemical Formula

C47-H51-N-O14

Molecular Weight

853

Therapeutic Category

Antineoplastic agent, microtubule inhibitor

Chemical Name

(2S,5R,7S,10R,13S)-10,20-Bis(acetoxy)-2-benzoyloxy-1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-13-yl (3S)-3-benzoylamino-3-phenyl-D-lactate

Foreign Names

• Paclitaxelum (Latin)
• Paclitaxel (German)
• Paclitaxel (French)
• Paclitaxel (Spanish)

Generic Names

• Paclitaxel (OS: BAN, USAN, DCF)
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Brand Names

• Abraxane
  Abraxis, Germany; Abraxis, United Kingdom; Abraxis Bio Science, United States; Abraxis BioScience, Australia; Abraxis BioScience, Canada



• Aclixel
  Armstrong, Mexico



• Anzatax
  Hospira, Australia; Hospira, Italy; Hospira, Singapore; Hospira, Taiwan; Mayne, Hong Kong; Mayne, Lithuania; Mayne, Malaysia; NaPro, Latvia; Orna, Turkey; Pharmaplan, South Africa; Tempo Scan Pacific, Indonesia



• Asotax
  Asofarma, Mexico; Raffo, Argentina



• Axitaxel
  Axios, Germany



• Biolyse Paclitaxel
  Key Oncologics, South Africa



• Biopaxel
  Biosintética, Brazil



• Biotax
  Faulding, Israel



• Biotaxel
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• Bristaxol
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• Britaxol
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• Cantaxel
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• Celltaxel
  Cell pharm, Germany



• Clitaxel
  Nolver, Venezuela; Pfizer, Argentina



• Cryoxet
  Cryopharma, Mexico



• Dalys
  Dosa, Argentina



• Drifen
  Richmond, Argentina; Richmond, Peru



• Ebetaxel
  Ebewe, Austria; Ebewe, Georgia; Ebewe, Israel; Ebewe, Tunisia; Ebewe, Vietnam; Ferron, Indonesia; Liba, Turkey



• Genaxol
  Union Lab, Taiwan



• Genexol
  Pezomed, Hungary; Samyang, Bulgaria; Samyang, Singapore



• Intaxel
  Biogalenic, Venezuela; Dabur, Georgia; Dabur, Hungary; Dabur, Sri Lanka; Dabur, Myanmar; Dabur, Philippines



• Medixel
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• Mitotax
  Dr Reddys, Sri Lanka; Dr Reddys, Myanmar; Dr. Reddy's, Russian Federation



• NeoTaxan
  NeoCorp, Germany



• Oncoplaxel
  Biotoscana, Chile



• Oncotaxen
  Sambrook, Greece



• Onxol
  Ivax, Czech Republic



• Ovapac
  Farmaten, Greece



• Paclikebir
  Aspen, Argentina



• Paclimedac
  Medac, Latvia; Medac, Slovakia



• Paclisachs
  Oncosachs, Germany



• Paclit
  Cancernova, Germany



• Paclitax
  Medicopharm, Germany; Pharmaceutical, Venezuela



• Paclitaxel Actavis
  Actavis, Austria; Actavis, Switzerland; Actavis, France; Actavis, Ireland; Actavis, Sweden; Actavis Group, Netherlands



• Paclitaxel All-Gen
  All-Gen, Netherlands



• Paclitaxel Arcana
  Arcana, Austria



• Paclitaxel Bendalis
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• Paclitaxel CF
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• Paclitaxel Dakota Pharm
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• Paclitaxel Delta
  Delta Farma, Argentina



• Paclitaxel Ebewe
  Ebewe, Belgium; Ebewe, Czech Republic; Ebewe, Estonia; Ebewe, France; Ebewe, Hungary; Ebewe, Lithuania; Ebewe, Latvia; Ebewe, Netherlands; Ebewe, Serbia; Ebewe, Russian Federation; Ebewe, Slovenia; InterPharma, New Zealand; Meda, Sweden; Sandoz, Switzerland; Würth, Croatia (Hrvatska)



• Paclitaxel EG
  Eurogenerics, Belgium



• Paclitaxel Ferrer Farma
  Ferrer, Spain



• Paclitaxel Fresenius Kabi
  Fresenius, Sweden



• Paclitaxel Fresenius
  Fresenius Kabi, Switzerland



• Paclitaxel Hexal
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• Paclitaxel Hospira
  Hospira, Austria; Hospira, Belgium; Hospira, France; Hospira, Netherlands; Hospira, Norway; Hospira, Slovakia; Hospira Nordic, Sweden



• Paclitaxel Iwa
  Iwa, Estonia



• Paclitaxel Kabi
  Fresenius, Germany; Fresenius, France



• Paclitaxel Lachema
  Pliva, Czech Republic; Pliva, Czech Republic



• Paclitaxel Mayne
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• Paclitaxel Meda
  Meda, Denmark



• Paclitaxel Merck
  Merck, Hungary; Merck Genericos, Spain



• Paclitaxel Microsules
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• Paclitaxel Mylan
  Mylan, Belgium; Mylan, Switzerland; Mylan, France; Mylan, Italy; Mylan, Netherlands



• Paclitaxel Normon
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• Paclitaxel onkovis
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• Paclitaxel PCH
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• Paclitaxel Pharmachemie
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• Paclitaxel Pliva
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• Paclitaxel Ratiopharm
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• Paclitaxel Rontag
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• Paclitaxel Sandoz
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• Paclitaxel Servycal
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• Paclitaxel Stada
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• Paclitaxel-EG
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• Paclitaxel-GRY
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• Paclitaxel-Lans
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• Paclitaxel-Teva
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• Pacliteva
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  Filaxis, Argentina



• Panataxel
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• Parexel
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• Taxomedac
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• Taycovit
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• Teva-Paclitaxel
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• Unitaxel
  Korea United Pharm, Georgia

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
SPC	Summary of Product Characteristics (UK)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.