HYDROQUINONE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

Tilgjengelig fra:

Syntenza Pharmaceuticals LLC

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

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.

Autorisasjon status:

unapproved drug other

Preparatomtale

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._
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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
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symptoms and life-threatening or less severe asthmatic episodes in
certain susceptible people. The
overall prevalence of sulfite sensitivity in t