País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
Genesis Pharmaceutical, Inc.
HYDROQUINONE
HYDROQUINONE 40 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Glytone Skin Lightening Gel is indicated for the gradual lightening 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 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.
Glytone Hydroquinone USP, 4% Skin Lightening Gel is available as follows: Store at room temperature of 68-77° F (20-25° C). Do not expose to heat above 86° F (30° C) or direct sunlight. Distributed by: Genesis Pharmaceutical, Inc. Parsippany, NJ 07054 U.S.A. 1-800-GLYTONE (459-8663) www.glytone-usa.com Rev. 112015
unapproved drug other
GLYTONE CLARIFYING- HYDROQUINONE GEL GENESIS PHARMACEUTICAL, 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._ ---------- GLYTONE HYDROQUINONE USP, 4% SKIN LIGHTENING GEL GLYTONE HYDROQUINONE USP, 4% SKIN LIGHTENING GEL RX ONLY FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE I. DESCRIPTION Each gram of Glytone Hydroquinone USP, 4% Skin Lightening Gel contains 40 mg of Hydroquinone USP in a gel base of Purified Water, Propylene Glycol, Carbomer 940, Sodium Bisulfite, Edetate Disodium, Sorbic Acid, and Glycerin. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C H O and molecular weight is 110.11. Hydroquinone has the following structural formula: HYDROQUINONE STRUCTURAL FORMULA II. 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) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the treated areas. III. INDICATIONS AND USAGE Glytone Skin Lightening Gel is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. 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. V. WARNINGS 6 6 2 A. Contains sodium bisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthma Leia o documento completo