Vaniqa Recall
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Questions & Answers
Side Effects & Adverse Reactions
Discontinue use if hypersensitivity occurs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
VANIQA (eflornithine hydrochloride) Cream, 13.9% is indicated for the reduction of unwanted facial hair in women.
VANIQA 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.
History
There is currently no drug history available for this drug.
Other Information
VANIQA 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 C 6H12F2N2O2• HCl•H2O, a molecular weight of 236.65 and the following structural formula:
Anhydrous eflornithine hydrochloride has an empirical formula C6H12F 2N2O2• 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.
Sources