GLYTONE SKIN LIGHTENING- hydroquinone gel

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Pierre Fabre USA Inc.

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Glytone Skin Lightening Gel is indicated for the gradual lightening 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 this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Vörulýsing:

Glytone Hydroquinone USP, 4% Skin Lightening Gel is available as follows: Store at room temperature of 68-77° F (20-25° C). Do not expose to heat above 86° F (30° C) or direct sunlight. Distributed by: Pierre Fabre USA, Inc. Parsippany, NJ 07054 1-800-GLYTONE (459-8663) www.glytone.com 83941L

Leyfisstaða:

unapproved drug other

Vara einkenni

GLYTONE SKIN LIGHTENING- HYDROQUINONE GEL
PIERRE FABRE USA 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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GLYTONE HYDROQUINONE USP, 4% SKIN LIGHTENING GEL
GLYTONE
HYDROQUINONE USP, 4%
SKIN LIGHTENING GEL
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
I. DESCRIPTION
Each gram of Glytone Hydroquinone USP, 4% Skin Lightening Gel contains
40 mg of Hydroquinone
USP in a gel base of Carbomer 940, Edetate Disodium, Glycerin,
Propylene Glycol, Purified Water,
Sodium Bisulfite, and Sorbic Acid. The chemical name for hydroquinone
is: 1,4-benzenediol. The
molecular formula is C
H
O
and molecular weight is 110.11. Hydroquinone has the following
structural formula:
II. 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) and suppression of other
melanocyte metabolic processes. Exposure to sunlight or ultraviolet
light will cause repigmentation of
the treated areas.
III. INDICATIONS AND USAGE
Glytone Skin Lightening Gel is indicated for the gradual lightening of
hyperpigmented skin conditions
such as chloasma, melasma, freckles, senile lentigines, and other
unwanted areas of melanin
hyperpigmentation.
IV. CONTRAINDICATIONS
Prior history of sensitivity or allergic reaction to this product or
any of its ingredients. The safety of
topical hydroquinone use during pregnancy or in children (12 years and
under) has not been established.
V. WARNINGS
A. Contains sodium bisulfite, a sulfite that may cause allergic-type
reactions (e.g. hives, itching,
wheezing, anaphylaxis, severe asthma attack) in certain susceptible
persons. The overall prevalence of
6
6
2
sulfite sensitivity in the general population is unknown and probably
low. Sulfite sensitivity is seen
more frequently in asthmatic than in nonasthmatic people.
B. May produce exogeno