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:

Preferred Pharmaceuticals Inc.

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 68788-6979-8) 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
PREFERRED 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._
----------
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 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
6
6
2
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