Data from FDA - Curated by EPG Health - Last updated 31 August 2017

Indication(s)

III. INDICATIONS AND USAGE SunVanish is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

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Advisory information

contraindications
IV. CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.
Special warnings and precautions
VI. PRECAUTIONS SEE WARNINGS A. Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should not be used in pregnant women. B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers. C. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age.
Adverse reactions
VII. ADVERSE REACTIONS No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Sensitivity to sodium metabisulfate is a potential. See WARNINGS.

Usage information

Dosing and administration
IX. DRUG DOSAGE AND ADMINISTRATION SunVanish should be applied in the morning to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential.
Pregnancy and lactation
B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers.

More information

Category Value
Agency product number G63QQF2NOX
Orphan designation No
Product NDC 64760-401
Date Last Revised 08-08-2014
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Genesis Pharmaceutical, Inc.