HYDROQUINONE 4%- hydroquinone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Acella Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

HYDROQUINONE 4% CREAM is available in a 1 oz (28.35 g) tube with (NDC 42192-151-01) Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROQUINONE 4%- HYDROQUINONE CREAM
ACELLA 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 4% 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, Capryloyl Glycine, C13-14 Isoparaffin, Glycerin,
Glycolic Acid, Kojic Acid,
Laureth-7, Lecithin, Polyacrylamide, Purified Water, Simmondsia
Chinensis (Jojoba) Seed
Oil, Sodium Hydroxide, Squalane and Xanthan Gum.
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)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
6
6
2
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 sensitivity in
the general population is
unknown and probably