Drug Catalog - Product Detail
ADAPALENE CREAM CRM 0.001 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0453-84 | PADAGIS | 45 | 0.1% | CREAM |
PACKAGE FILES
Generic Name
ADAPALENE
Substance Name
ADAPALENE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA020748
Description
DESCRIPTION Adapalene Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. 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, sparingly 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. structural formula image
How Supplied
HOW SUPPLIED Adapalene Cream, 0.1% is available as follows: 45 g tube (NDC 45802- 453 -84)
Indications & Usage
INDICATIONS AND USAGE Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adapalene Cream, 0.1% should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Cream, 0.1%.