Ketrel 0.05% - Tretinoin Cream

PRESCRIPTION ONLY - MEDICAL ASSESSMENT FORM REQUIRED

Tretinoin Cream, 0.05% is a prescription-only medication indicated as an adjunctive agent for use in the treatment of mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skincare and sun avoidance programs.

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.

• Ketrel should be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 30) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone.

• The effectiveness of Ketrel [Tretinoin Cream, USP (Emollient) 0.05%] in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of Tretinoin Cream, USP (Emollient) 0.05%. Thus the effectiveness and safety of Ketrel in these populations are not known at this time.