Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Tretinoin (UNII: 5688UTC01R) (Tretinoin - UNII:5688UTC01R)
ZO Skin Health, Inc.
Tretinoin
Tretinoin 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Tretinoin Cream, USP (Emollient) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs (see bullet 3 for populations in which effectiveness has not been established). TRETINOIN CREAM, USP (EMOLLIENT) DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin. - Tretinoin Cream, USP
Tretinoin Cream, USP (Emollient) 0.05% is available in this size: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.
Abbreviated New Drug Application
TRETINOIN (EMOLLIENT)- TRETINOIN CREAM ZO SKIN HEALTH, INC. ---------- TRETINOIN CREAM, USP (EMOLLIENT) 0.05% FOR TOPICAL USE ON THE FACE ONLY. DESCRIPTION Tretinoin Cream, USP (Emollient) 0.05% contains the active ingredient tretinoin (a retinoid) in an emollient cream base. Tretinoin is a yellow-to-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclonexen-1-yl)-2,4,6,8- nonatetraenoic acid. Tretinoin is also referred to as all-_trans_-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below. Tretinoin is available as Tretinoin Cream, USP (Emollient) at a concentration of 0.05% w/w in a water- in-oil emulsion formulation consisting of light mineral oil, sorbitol solution, hydroxyoctacosanyl hydroxystearate; methoxy PEG-22/dodecyl glycol copolymer, PEG-45/dodecyl glycol copolymer, stearoxytrimethylsilane and stearyl alcohol, dimethicone 50 cs, methylparaben, edetate disodium, propylparaben, butylated hydroxytoluene, citric acid monohydrate, and purified water. CLINICAL PHARMACOLOGY The exact mechanism of action of tretinoin is unknown although retinoids are believed to exert an effect on the growth and differentiation of various epithelial cells. When applied topically, however, there was no noted increase in desmosine, hydroxyproline, or elastin mRNA in human skin. In addition, the role of the irritative nature of this product in effecting the positive effects attributed to this product for its indication has not yet been fully determined. The transdermal absorption of tretinoin from various topical formulations ranged from 1% to 31% of applied dose, depending on whether it was applied to healthy skin or dermatitic skin. When percutaneous absorption of Tretinoin Cream, USP (Emollient Baca dokumen lengkapnya