HYDROQUINONE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TWi Pharmaceuticals, Inc.

INN (International Name):

HYDROQUINONE

Composition:

HYDROQUINONE 40 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.35 g) tube (NDC 24979-141 -36)

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROQUINONE- HYDROQUINONE CREAM
TWI PHARMACEUTICALS, 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._
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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 glyceryl monostearate, mineral oil, PEG-25
propylene glycol stearate,
polyoxyl 40 stearate, propylene glycol, propylparaben, purified water,
sodium metabisulfite, squalane
and stearic acid. 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
6
6
2
1
2
3
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 sensitivity in the general population is
un