Drug Catalog - Product Detail
ADAPALENE BENAZ GEL 0.1%/2.5 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0869-48 | PRASCO LABORATORIES | 45 | 0.1-2.5% | GEL |
PACKAGE FILES
Generic Name
ADAPALENE AND BENZOYL PEROXIDE
Substance Name
ADAPALENE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA022320
Description
11 DESCRIPTION Adapalene and Benzoyl Peroxide gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula: Adapalene: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.5 Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide: Molecular formula: C 14 H 10 O 4 Molecular weight: 242.23 Adapalene and Benzoyl Peroxide gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. adapalene structure bp structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene and Benzoyl Peroxide gel, 0.1% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram pump NDC 66993-869-48 Storage and handling - Store at 25ºC; excursions permitted to 15º - 30ºC (59º - 86ºF). - Protect from light. - Keep out of reach of children. - Keep away from heat. - Keep tube tightly closed.
Indications & Usage
1 INDICATIONS AND USAGE Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and Benzoyl Peroxide gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For topical use only; Adapalene and Benzoyl Peroxide gel is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Adapalene and Benzoyl Peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene and Benzoyl Peroxide gel is not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply a thin film of Adapalene and Benzoyl Peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. ( 2 )