RVP

Drug Catalog - Product Detail

ADAPALENE TOPICAL GEL GEL 0.001 45GM

NDC Mfr Size Str Form
68462-0403-55 GLENMARK PHARMACEUTICALS 45 0.1% GEL
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Description
DESCRIPTION: Adapalene Gel, 0.1%, containing adapalene, USP is used for the topical treatment of acne vulgaris. Each gram of adapalene gel, 0.1% contains adapalene, USP 0.1% (1 mg) in a vehicle consisting of carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene, USP is a white to off-white powder which is sparingly soluble in tetrahydrofuran, very slightly soluble in diethyl ether. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.52 g/mol. Adapalene, USP is represented by the following structural formula: structural-formula
How Supplied
HOW SUPPLIED: Adapalene gel, 0.1% is supplied in the following size: 45 g laminate tube NDC 68462-403-55 Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
INDICATIONS AND USAGE: Adapalene gel, 0.1% is indicated for the topical treatment of acne vulgaris.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Adapalene gel, 0.1% should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.