Important safety information Prescribing Information

References

  1. Thiboutot D, Gollnick H, Bettoli V, et al; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne Group. J Am Acad Dermatol. 2009;60(5)(suppl):S1-S50.
  2. Gollnick HPM, Draelos Z, Glenn MJ, et al; Adapalene-BPO Study Group. Adapalene-benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189.
  3. Stein Gold L, Tan J, Cruz-Santana A, et al; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009;82:110-116.
  4. Data on file. Galderma Laboratories, L.P.
  5. Differin® (adapalene) Cream 0.1% [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; June 2004.
  6. Tanghetti E. The evolution of benzoyl peroxide therapy. Cutis. 2008;82(5)(suppl):5-11.
  7. Zaenglein AL, Thiboutot DM. Expert committee recommendations for acne management. Pediatrics. 2006;118(3):1188-1199.
  8. Thiboutot DM, Weiss J, Bucko A, et al; Adapalene-BPO Study Group. Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study. J Am Acad Dermatol. 2007;57(5):791-799.
  9. Pariser DM, Westmoreland P, Morris A, Gold MH, Liu Y, Graeber M. Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris. J Drugs Dermatol. 2007;6(9)899-905.

Important Safety Information

Epiduo® Gel is a retinoid and antimicrobial combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. The most common adverse events associated with use of Epiduo® Gel are erythema, scaling, dryness, stinging and burning. In addition, in clinical trials, adverse events reported in greater than 1% of patients treated with the Gel included contact dermatitis and skin irritation. Excessive exposure to sunlight and sunlamps should be avoided during treatment, and use of sunscreen products and protective clothing is recommended. Concomitant use of irritating topical products (like products containing resorcinol, salicylic acid or sulfur) should be avoided. Epiduo® Gel has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C. Please see full Prescribing Information.

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