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INDICATIONS AND USAGE
(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 SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.
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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 well-controlled trials (see
WARNINGS
section).
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DOSAGE AND ADMINISTRATION
General
Application may cause excessive irritation in the skin of certain sensitive individuals. In cases where it has been necessary to temporarily discontinue therapy, or the dosing has been reduced to an interval the patient can tolerate, therapy can be resumed, or the frequency of application can be 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.
Apply a pea-sized amount once a day at bedtime to lightly cover the entire face including the eyelids if desired. Facial moisturizers may be used as frequently as desired. If any makeup is present it should be removed before applying AVAGE®
(tazarotene) Cream 0.1% to the face. If the face is washed or a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients or moisturizers are used, they can be applied either before or after application of tazarotene cream ensuring that the first cream or lotion has absorbed into the skin and has dried completely. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. If the frequency of dosing is reduced, it should be noted that efficacy at a reduced frequency of application has not been established. The duration of the mitigating effects on facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines following discontinuation of AVAGE®
(tazarotene) Cream 0.1% has not been studied.
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HOW SUPPLIED
AVAGE®
Cream is available in a concentration of 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in a 30 g size.
AVAGE®
Cream 0.1%
30 g NDC 0023-9236-30
Store at 25°C (77°F).
Excursions permitted from -5° to 30°C (23° to 86°F).
Rx only
Revised: 01/2012
© 2012 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Made in the U.S.A.
71568US13C
Pharmacist: Please cut or tear at dotted line and provide this patient package insert to your customer.
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