"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.
(eflornithine hydrochloride) Cream, 13.9%
For topical dermatological use only. Not for ophthalmic, oral or intravaginal use.
VANIQA (eflornithine) is a cream containing 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as eflornithine hydrochloride monohydrate (150 mg/g).
Chemically, eflornithine hydrochloride is (±) -2- (difluoromethyl) ornithine monohydrochloride monohydrate, with the empirical formula C6H12F2N2O2•HCl•H2O, a molecular weight of 236.65 and the following structural formula:
Anhydrous eflornithine hydrochloride has an empirical formula C6H12F2N2O2• HCl and a molecular weight of 218.65.
Other ingredients include: ceteareth-20, cetearyl alcohol, dimethicone, glyceryl stearate, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, stearyl alcohol and water.
What are the possible side effects of eflornithine topical (Vaniqa)?
Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.
Hair bumps (folliculitis) may also occur. If these continue, contact your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to...
What are the precautions when taking eflornithine (Vaniqa)?
Before using this product, tell your doctor or pharmacist if you are allergic to eflornithine; or if you have any other allergies. This product may contain inactive ingredients (such as methylparaben), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: cuts/infections/sores on face.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 5/12/2008
This monograph has been modified to include the generic and brand name in many instances.
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