GLYTONE SKIN LIGHTENING- hydroquinone cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Pierre Fabre USA Inc.

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Glytone Skin Lightening Cream 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.

Dettagli prodotto:

Glytone Hydroquinone USP, 4% Skin Lightening Cream 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 83931L

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

GLYTONE SKIN LIGHTENING- HYDROQUINONE CREAM
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 CREAM
GLYTONE
HYDROQUINONE USP, 4%
SKIN LIGHTENING CREAM
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
I. DESCRIPTION
Each gram of Glytone Hydroquinone USP, 4% Skin Lightening Cream
contains 40 mg of Hydroquinone
USP in a cream base of Cetostearyl Alcohol, Glycerin, Mineral Oil,
Petrolatum, Propylene Glycol,
Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, and
Sorbic Acid. The chemical name for
hydroquinon 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 Cream 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
6
6
2
A. Contains sodium metabisulfite, 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
sulfite sensitivity in the general population is unknown and probably
low. Sulfite sensitivity is seen
more frequently in asthm