HYDROQUINONE cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)

Commercializzato da:

Bi-Coastal Pharma International LLC

INN (Nome Internazionale):

Hydroquinone

Composizione:

Hydroquinone 40 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.35 g) tube (NDC 42582-700-01) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

HYDROQUINONE- HYDROQUINONE CREAM
BI-COASTAL PHARMA INTERNATIONAL 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.
6
6
2
1
2
3
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 in certain
susceptible people. The overall prevalence of sulfite sensiti