Drug Catalog - Product Detail
ADAPALENE GEL PUMP 0.3% 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0884-48 | PRASCO LABORATORIES | 45 | 0.3% | GEL |
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Description
11 DESCRIPTION Adapalene Gel, 0.3% contains Active: adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris. Inactive: consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, 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. adap-gel-chem-struct
How Supplied
16 HOW SUPPLIED/ STORAGE AND HANDLING Adapalene Gel, 0.3% is supplied in the following size. 45g tube – NDC 66993-884-45 45g pump – NDC 66993-884-48 Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND 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. ( 1 )
Dosage and Administration
2 DOSAGE AND 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. ( 2 ) For topical use only. Not for ophthalmic, oral or intravaginal use. ( 2 )