DESCRIPTION

Tretinoin is a yellow to light 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-trans¾retinoic acid. (C₂₀H₂₈O₂; molecular weight 300.44 vitamin A acid.

Retin-A Cream, Gel and Liquid: Retin-A Gel, Cream and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. Retin-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Retin-A Cream contains tretinoin in either of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Retin-A Liquid contains tretinoin 0.05% by weight, polyethylene glycol 400, butylated hydroxytoluene and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 55%.

Retin-A Micro: Retin-A Micro microsphere, 0.1%, is a formulation containing 0.1% by weight tretinoin for the topical treatment of acne vulgaris. This formulation uses patented acrylates copolymer porous microspheres (Microsponge System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. Other components of this formulation are purified water, carbomer 934P, glycerin, disodium EDTA, propylene glycol, sorbic acid, PPG-20 methyl glucose ether distearate, cyclomethicone and dimethicone copolyol, benzyl alcohol, trolamine, and butylated hydroxytoluene.

Renova Emollient Cream: Renova 0.05% contains the active ingredient tretinoin (a retinoid) in an emollient cream base. Tretinoin is available as Renova 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 copolmyer, PEG-45/dodecyl glycol copolymer, stearoxytrimethylsilane and stearyl alcohol, dimethicone 50 cs, methylparaben, edetate disodium, quaternium-15, butylated hydroxytoluene, citric acid monohydrate, fragrance; and purified water.

Avita Cream and Gel: Cream: A topical retinoid, contains tretinoin 0.025% by weight in a hydrophilic cream vehicle of stearic acid, polyolprepolypmer-2, isopropyl myristate, polyoxy 40 stearate, propylene glycol, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Gel: A topical retinoid, contains tretinoin 0.025% by wight in a gel vehicle of butylated hyroxytoluene, hydroxypropyl cellulose, polyolprepolymer-2, and ethanol (denatured with tert¾butyl alcohol and brucine sulfate) 83% w/w.

CATEGORIES, BRAND NAMES

CATEGORIES: Acne vulgaris; Pregnancy Category C; FDA Approval Pre 1982; Top 200 Drugs; Patent Expiration 2005 Oct; Orphan Drugs

FDA Drug Classes: Products; Antineoplastics; Dermatologics/Miscellaneous

BRAND NAMES:

BRAND NAMES: Aberel; Aberela; A-Acido; Acid A Vit; Acnavit; Acta; Airol; Alten; Avita; Avitcid; Avitoin; Cordes-Vas; Cordes VAS; Derm A; Dermairol; Dermojuventus; Effederm; Epi-Aberel; Eudyna; Locacid; Locion De Tretinoina; Relief; Renova; Retavit; Retiderma; Retin-A; Retin A; Retinoic Acid; Retiol; Retrieve Cream; SteiVAA; Stieva-A; Stieva A; Vesanoid; Vitamin A Acid
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Aberel (France)
Aberela (Sweden)
A-Acido (Argentina)
Acid A Vit (Belgium; Netherlands)
Acta (Hong-Kong)
Airol (Argentina; Czech-Republic; Greece; Israel; Italy; Malaysia; Mexico; Norway; Philippines; South-Africa; Switzerland; Taiwan)
Alten (Hong-Kong)
Avitcid (Finland)
Cordes VAS (Germany)
Derm A (Philippines)
Dermairol (Sweden)
Effederm (France)
Epi-Aberel (Germany)
Eudyna (Colombia; Costa-Rica; Dominican-Republic; Ecuador; El-Salvador; Germany; Guatemala; Honduras; Hong-Kong; India; Indonesia; Malaysia; Nicaragua; Panama; Taiwan; Thailand)
Locacid (Israel)
Locion De Tretinoina (Colombia)
Retavit (Israel)
Retiderma (Spain)
Retin A (Austria; Bahamas; Barbados; Belize; Bermuda; Bulgaria; Curacao; Czech-Republic; France; Greece; Guyana; Hungary; Israel; Jamaica; Netherland-Antilles; Portugal; Surinam; Trinidad)
Retiol (Taiwan)
Retrieve Cream (Australia)
Stieva-A (Australia; Korea; Malaysia; Mexico; Thailand)
Stieva A (Canada)
Vitamin A Acid (Canada)