HYDROQUINONE- hydroquinone cream
Perrigo New York Inc
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Skin Bleaching Cream
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg hydroquinone USP, in a vanishing cream base of glyceryl monostearate, mineral oil, PEG-25 propylene glycol stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium metabisulfite, squalane and stearic acid. Chemically, hydroquinone is C6 H6 O2 and has a molecular weight of 110.11.
The chemical name is 1,4 dihydroxybenzene.
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (Denton, C. et al., 1952)1 and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974)2. Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978)3.
INDICATIONS AND USAGE
Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Information for Patients -
Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing.
Avoid contact with eyes and mucous membranes.
Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
Drug Interactions -
Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Carcinogenesis, Mutagenesis, Impairment of Fertility -
Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.
Pregnancy Category C -
Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.
Nursing Mothers -
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.
Pediatric Use -
Safety and effectiveness for pediatric patients below the age of 12 years have not been established.
DOSAGE AND ADMINISTRATION
Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.