Hydroquinone , 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.
Hydroquinone Preparations
Hydroquinone is a topical depigmentating agent that produces a reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine and suppressing melanocyte metabolic processes.
Hydroquinone , 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.
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.
Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.
Dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately
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.
There have been no systemic reactions from the use of topical hydroquinone in Hydroquinone. However, treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.
Store in a cool and dry place, protected from light.
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