ADVERSE EVENTS, PRODUCT COMPLAINTS, AND MEDICAL
INFORMATION
Contact: 1-800-328-0255
Site References:
1.Atopiclair nonsteroidal cream manufacturer’s prescribing
information. 2.Abramovits W, Boguniewicz M. A multicenter, randomized,
vehicle-controlled clinical study to examine the efficacy and safety
of MAS063DP (Atopiclair™) in the management of mild to
moderate atopic dermatitis. J Drugs Dermatol. 2006;5(3):236-244. 3.Boguniewicz M, Zeichner JA, Eichenfield LF, et al. MAS063DP is effective
monotherapy for mild to moderate atopic dermatitis in infants and children: a
multicenter, randomized, vehicle-controlled study. J Pediatr.
2008;152(6):854-859. 4.Data on file. Graceway Pharmaceuticals, LLC. 5.Food and Drug Administration. Center for Device and Radiologic
Health. Device advice. Available at
http://69.20.19.211/cdrh/devadvice/312.html. Accessed April
21,2008. 6.Zhai H, Villarama CD, Hafeez ZH, Maibach HI. Efficacy of a
topical agent, MAS063D (Atopiclair), in the treatment of sodium
lauryl sulphate-induced irritant contact dermatitis. Exog Dermatol.
2003;2:301-305. 7.Saeedi M, Morteza-Semnani K, Ghoreishi M-R. The treatment of atopic dermatitis with licorice gel. J Dermatol Treat. 2003;14(3):153-157.
Under the supervision of a health care professional,
Atopiclair nonsteroidal cream is indicated to manage and
relieve the itching, burning and pain experienced with
various types of dermatoses, including atopic dermatitis and
allergic contact dermatitis. Atopiclair nonsteroidal cream
helps to relieve dry, waxy skin by maintaining a moist skin
environment, which is beneficial to the healing process.
Atopiclair nonsteroidal cream does not contain milk, wheat,
peanut or animal derivatives. Atopiclair nonsteroidal cream
does contain shea butter (butyrospermum parkii), a
derivative of shea nut oil (not peanut oil). Patients with a
known allergy to nuts or nut oils should consult their
physician before using this topical preparation.
Frequently reported adverse events in Atopiclair-treated and vehicle-treated groups were burning (6.9% vs 7.1%) and stinging (8.3% vs 2.8%).
