HYDROQUINONE cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Marlex Pharmaceuticals, Inc.

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

HYDROQUINONE USP, 4% SKIN BLEACHING CREAM is available in a 1 oz (28.35 g) tube with (NDC 10135-0724-99) Store at 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature].

Status autorizacije:

unapproved drug other

Svojstava lijeka

HYDROQUINONE- HYDROQUINONE CREAM
MARLEX 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- HYDROQUINONE CREAM
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, in a cream base of Glyceryl Monostearate, Mineral Oil,
PEG-25 Propylene
Glycol Stearate, Polyoxl-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 CREAMis indicated for the gradual
bleaching of hyperpigmented skin conditions such as chloasma, melasma,
freckles,
senile lentigines, and other unwanted areas of melanin
hyperpigmentation.
CONTRAINDICATIONS
6
6
2
1
2
3
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 sensitivity in
the ge