Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
Syntenza Pharmaceuticals LLC
TOPICAL
PRESCRIPTION DRUG
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. 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.
Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.35 g) tube (NDC 72056-060-01) Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (15-30°C) (59-86°F). Darkening of this product is normal. This will not affect performance or safety.
unapproved drug other
HYDROQUINONE- HYDROQUINONE CREAM SYNTENZA PHARMACEUTICALS LLC _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._ ---------- HYDROQUINONE USP, 4% SKIN BLEACHING CREAM RX ONLY FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg hydroquinone USP, in a vanishing cream base of aqua (water), ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol and tocopheryl acetate. Chemically, hydroquinone is C H O and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: CLINICAL PHARMACOLOGY 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) and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974) . Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978) . 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. CONTRAINDICATIONS 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. WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic 6 6 2 1 2 3 symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in t Lestu allt skjalið