HYDROQUINONE 4%- hydroquinone cream

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Akron Pharma Inc

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Резиме производа:

HYDROQUINONE USP, 4% SKIN BLEACHING CREAM  is available in a 1 oz (28.35 g) tube with (NDC 71399-0400-1) Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature] All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.  Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency.  Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004

Статус ауторизације:

unapproved drug other

Карактеристике производа

HYDROQUINONE 4%- HYDROQUINONE CREAM
AKRON PHARMA 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 4% CREAM
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 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
6
6
2
1
2
3
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 low.