Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)
Mylan Pharmaceuticals Inc.
TOPICAL
PRESCRIPTION DRUG
Tretinoin 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. Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
Tretinoin is supplied as: Tretinoin Cream NDC Code Strength/Form Qty 0378-8082-20 0378-8082-45 0.025% Cream 0.025% Cream 20 g 45 g 0378-8083-20 0378-8083-45 0.05% Cream 0.05% Cream 20 g 45 g 0378-8084-20 0378-8084-45 0.1% Cream 0.1% Cream 20 g 45 g Tretinoin Gel NDC Code Strength/Form Qty 0378-8085-15 0378-8085-45 0.01% Gel 0.01% Gel 15 g 45 g 0378-8086-15 0378-8086-45 0.025% Gel 0.025% Gel 15 g 45 g Storage Conditions: Tretinoin Gel, 0.025% and 0.01%: store below 86°F. Tretinoin Cream, 0.1%, 0.05%, and 0.025%: store below 80°F. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada Revised: 02/2024 VAL:TRETCG:R2 9631002
New Drug Application Authorized Generic
TRETINOIN- TRETINOIN CREAM TRETINOIN- TRETINOIN GEL MYLAN PHARMACEUTICALS INC. ---------- TRETINOIN CREAM – TRETINOIN GEL CREAM – GEL FOR TOPICAL USE ONLY DESCRIPTION Tretinoin Cream and Tretinoin Gel are used for the topical treatment of acne vulgaris. Tretinoin 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. Tretinoin Cream contains tretinoin in one 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. 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 Tretinoin 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 tretinoin, 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 Baca dokumen lengkapnya