Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
AvPAK
TOPICAL
PRESCRIPTION DRUG
HYDROQUINONE 4% 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. Safety and effectiveness for pediatric patients below the age of 12 years have not been established.
HYDROQUINONE 4% CREAM is available in a 1 oz (28.35 g) tube with (NDC 50268-343-28) Store at 20° - 25°C (68° - 77°F; [see USP Controlled Room Temperature] KEEP OUT OF REACH OF CHILDREN Tamper Evident: Do not use if foil seal is missing or damaged. Manufactured for: AvKARE Pulaski, TN 38478 Rev. 10/2020 AV 10/2020
unapproved drug other
HYDROQUINONE 4%- HYDROQUINONE CREAM AVPAK _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 4% CREAM SKIN BLEACHING CREAM Skin Bleaching Cream Rx Only FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Each gram of HYDROQUINONE 4% CREAM contains 40 mg hydroquinone, in a cream base of Alcohol, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Glycerin, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-4-Oleate, Purified Water, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Metabisulphite, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), and Xanthan Gum. Chemically, hydroquinone is C6H6O2 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)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 4% 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 symptoms and life-threatening or less severe asthmatic episodes i Přečtěte si celý dokument