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(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling).
Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution is indicated for the treatment of solar lentigines.
Solagé should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program where the patient should primarily either avoid the sun or use protective clothing.
Neither the safety nor effectiveness of Solagé for the prevention or treatment of melasma or postinflammatory hyperpigmentation has been established.
The efficacy of using Solagé daily for greater than 24 weeks has not been established.
DOSAGE AND ADMINISTRATION
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Information. Apply Solagé to the solar lentigines using the applicator tip while avoiding application to the surrounding skin. Use twice daily, morning and evening at least 8 hours apart, or as directed by a physician. Patients should not shower or bathe the treatment areas for at least 6 hours after application of Solagé. Special caution should be taken when applying Solagé to avoid the eyes, mouth, paranasal creases, and mucous membranes.
Application of Solagé may cause transitory stinging, burning or irritation.
Improvement continues gradually through the course of therapy and should be apparent by 24 weeks. Patients should avoid exposure to sunlight (including sunlamps) or wear protective clothing while using Solagé. Data are not available to establish how or whether Solagé is degraded (either by sunlight or by normal interior lighting) following application to the skin.
With discontinuation of Solagé therapy, a majority of patients will experience some repigmentation over time of their lesions.
Applications of larger amounts of medication or more frequently than recommended will not lead to more rapid or better results, and marked redness, peeling, irritation, or hypopigmentation (abnormal lightening) of the skin may occur.
Patients treated with Solagé may use cosmetics but should wait 30 minutes before applying.
Not for oral, ophthalmic or intravaginal use.
Dosage Forms And Strengths
Mequinol 2% and tretinoin 0.01%, by weight, in a solution base of ethyl alcohol (77.8% v/v)
Solegé (mequinol 2%, tretinoin 0.01%) Topical Solution is available in 30mL plastic bottles with an applicator. NDC 13478-001-01
The bottle should be protected from light by continuing to store in the carton after opening. Store at 25°C (77°F); excursions permitted to 15° -30°C (59° - 86°F).
FLAMMABLE. Keep away from heat and open flame.
Keep out of reach of children.
This Patient Information leaflet has been approved by the U.S. Food and Drug
Administration. Revised 07 Dec 2009.
Marketed by: Stiefel Laboratories, Inc. 255 Alhambra Circle Coral Gables, FL 33134. Manufactured by: Contract Pharmaceutical Laboratories, Buffalo, NY 14213 USA. Questions? Call 1-866-440-5508. Serious side effects associated with use of this product may be reported to this number.
Last reviewed on RxList: 1/19/2010
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