"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
VANIQA (eflornithine hydrochloride) Cream, 13.9% is indicated for the reduction of unwanted facial hair in women.
VANIQA (eflornithine) has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.
DOSAGE AND ADMINISTRATION
Apply a thin layer of VANIQA (eflornithine hydrochloride) Cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with VANIQA (eflornithine) . (VANIQA (eflornithine) should be applied at least 5 minutes after hair removal.) Cosmetics or sunscreens may be applied over treated areas after cream has dried.
VANIQA (eflornithine hydrochloride) Cream, 13.9% is available as:
30 gram tube NDC 67402-040-30
2-30 gram tubes NDC 67402-040-32
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature] Do not freeze. See tube crimp and carton end for expiration date and lot number.
Distributed By: SkinMedica, Inc. Carlsbad, CA 92010. www.skinmedica.com. Revised 09/2006. FDA Rev date: 9/5/2001This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/12/2008
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