Product Description.:
AVAGE
(tazarotene) Cream, 0.1%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DRUG DESCRIPTION
AVAGE? Cream is a white cream and contains the compound tazarotene this formulation of tazarotene cream is also marketed for the treatment of plaque psoriasis and acne vulgaris as TAZORAC? (tazarotene) Cream, 0.1%.
Contains
Active: Tazarotene 0.1% (w/w)
Preservative: Benzyl alcohol 1.0% (w/w)
Inactives: Carbomer 934P, carbomer 1342, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium thiosulfate, sorbitan monooleate and sodium hydroxide to adjust the pH.
INDICATIONS
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)
AVAGE? (TAZAROTENE) Cream 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs. AVAGE? (TAZAROTENE) Cream 0.1% DOES NOT ELIMINATE or PREVENT WRINKLES, REPAIR SUNDAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.
* AVAGE? (TAZAROTENE) Cream 0.1% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
* AVAGE? (TAZAROTENE) Cream 0.1% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing.
* Neither the safety nor the effectiveness of AVAGE? (TAZAROTENE) Cream 0.1% for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna has been established.
* Neither the safety nor the efficacy of using AVAGE? (TAZAROTENE) Cream 0.1% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and wellcontrolled trials.
SIDE EFFECTS
In human dermal safety studies, tazarotene 0.05% and 0.1% creams did not induce allergic contact sensitization, phototoxicity or photoallergy.
