RVP

Drug Catalog - Product Detail

ADAPALENE GEL PUMP GEL 0.003 45GM

NDC Mfr Size Str Form
00781-7142-70 SANDOZ 45 0.3% NA
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Description
11 DESCRIPTION Adapalene Gel USP, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula. 14a84173-figure-01
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene Gel USP, 0.3% is supplied in the following size. 45 g tube – NDC 0781-7142-19 45 g pump - NDC 0781-7142-70 Storage: Store at 20° – 25ºC (68º – 77ºF); excursions permitted to 15º – 30ºC (59º – 86ºF) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.
Indications & Usage
1 INDICATIONS & USAGE Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Dosage and Administration
2 DOSAGE & ADMINISTRATION Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel, 0.3%. Patients should be instructed to minimize sun exposure. Patients may be instructed to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. For topical use only. Not for ophthalmic, oral or intravaginal use. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. For topical use only. Not for ophthalmic, oral or intravaginal use.