Drug Catalog - Product Detail
TRETINOIN MICRO 0.001 GEL 20GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-8093-20 | MYLAN | 20 | 0.1% | GEL |
PACKAGE FILES
Generic Name
TRETINOIN
Substance Name
TRETINOIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA020475
Description
11 DESCRIPTION Tretinoin Gel Microsphere , 0.1% and 0.04% is a white to very pale yellow opaque gel for topical treatment of acne vulgaris. 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. It is a member of the retinoid class of compounds 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: Each gram of Tretinoin Gel Microsphere , 0.1%, contains 1 mg of tretinoin. Each gram of Tretinoin Gel Microsphere , 0.04%, contains 0.4 mg of tretinoin. The formulation uses methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE ® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. 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. Tretinoin Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tretinoin Gel Microsphere is opaque and white to very pale yellow in color. Tretinoin Gel Microsphere , 0.1%, is supplied in 20 gram tube (NDC 0378-8093-20), 45 gram tube (NDC 0378-8093-45) and 50 gram pump (NDC 0378-8093-50). Tretinoin Gel Microsphere , 0.04%, is supplied in 20 gram tube (NDC 0378-8092-20), 45 gram tube (NDC 0378-8092-45) and 50 gram pump (NDC 0378-8092-50). 16.2 Storage Conditions 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. Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Tretinoin Gel Microsphere is a retinoid indicated for topical application in the treatment of acne vulgaris. Tretinoin Gel Microsphere is a retinoid, indicated for topical treatment of acne vulgaris. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Not for ophthalmic, oral, or intravaginal use. Tretinoin Gel Microsphere should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area in a thin layer. Areas to be treated should be cleansed thoroughly before the medication is applied. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy [see Adverse Reactions (6.1) ]. Therapeutic results may be noticed after two weeks, but more than seven weeks of therapy are required before consistent beneficial effects are observed. Tretinoin Gel Microsphere should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. Patients treated with Tretinoin Gel Microsphere may use cosmetics. Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Tretinoin Gel Microsphere . It also is advisable to allow the effects of such preparations to subside before use of Tretinoin Gel Microsphere is begun. • Apply a thin layer of Tretinoin Gel Microsphere once daily, before bedtime, to skin where lesions occur. Keep away from eyes, mouth, nasal creases, and mucous membranes. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )