Drug Catalog - Product Detail
TRETINOIN GEL MICRO GEL 0.001 50GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0513-85 | OCEANSIDE PHARMACEUTICALS | 50 | 0.1% | GEL |
PACKAGE FILES
Generic Name
TRETINOIN
Substance Name
TRETINOIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA020475
Description
11 DESCRIPTION Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C 20 H 28 O 2 and the following chemical structure: Tretinoin Gel Microsphere (tretinoin) gel is for topical use. Each gram of Tretinoin Gel Microsphere gel: • 0.04%, contains 0.4 mg of tretinoin • 0.08%, contains 0.8 mg of tretinoin • 0.1%, contains 1 mg of tretinoin The formulation contains methyl methacrylate/glycol dimethacrylate crosspolymer (MICROSPONGE ® System), propylene glycol dicaprylate/dicaprate and butylated hydroxytoluene. Other components consist of benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and dimethicone copolyol, disodium EDTA, glycerin, PPG-20 methyl glucose ether distearate, propylene glycol, purified water, sorbic acid, and trolamine. A structure of a chemical formula AI-generated content may be incorrect.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Tretinoin Gel Microsphere (tretinoin) is opaque and white to very pale yellow in color and is supplied as follows: Strength Amount of Tretinoin in One Gram of Gel Quantity/Package Type NDC 0.04% 0.4 mg 20 gram tube 68682-514-92 45 gram tube 68682-514-94 50 gram pump 68682-514-95 0.08% 0.8 mg 50 gram pump 68682-515-95 0.1% 1 mg 20 gram tube 68682-513-82 45 gram tube 68682-513-84 50 gram pump 68682-513-85 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store pump upright.
Indications & Usage
1 INDICATIONS AND USAGE Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Tretinoin Gel Microsphere is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. • Prior to Tretinoin Gel Microsphere use, thoroughly cleanse area(s) with a mild, non-medicated cleanser then pat the skin dry. • When applying Tretinoin Gel Microsphere, keep away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Apply a thin layer of Tretinoin Gel Microsphere (0.04%, 0.08%, or 0.1%) to skin where acne lesions appear (cover the entire affected area), once daily in the evening. Do not apply more than a thin layer [see Warning and Precautions (5.1) ] . Improvements in acne lesions may be noticed after two weeks of Tretinoin Gel Microsphere therapy, but more than seven weeks of therapy may be needed for sustained benefit. If Tretinoin Gel Microsphere was temporarily discontinued due to local adverse reactions, Tretinoin Gel Microsphere therapy may be resumed upon resolution of local adverse reactions. • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) • Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes. ( 2 ) • Apply a thin layer of Tretinoin Gel Microsphere to skin where acne lesions appear (cover the entire affected area) (0.04%, 0.08%, or 0.1%) once daily in the evening. (2)