GLYTONE CLARIFYING SUNVANISH WITH SUNSCREEN hydroquinone cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Genesis Pharmaceutical, Inc.

INN (International Name):

HYDROQUINONE

Sammensætning:

HYDROQUINONE 40 mg in 1 g

Recept type:

PRESCRIPTION DRUG

Autorisation status:

unapproved drug other

Produktets egenskaber

GLYTONE CLARIFYING SUNVANISH WITH SUNSCREEN- HYDROQUINONE CREAM
GENESIS PHARMACEUTICAL, 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 CLARIFYING SUNVANISH WITH SUNSCREEN
SKIN BLEACHING SUNVANISH
WITH SUNSCREEN
HYDROQUINONE USP, 4%
RX ONLY
FOR EXTERNAL USE ONLY
I. DESCRIPTION
Each 1 gram dose of SunVanish contains 40 mg of Hydroquinone USP, 75
mg of Octinoxate, 50 mg of
Oxybenzone, 20 mg of Avobenzone, and 18.6 mg of Octocrylene in a cream
base of Purified Water,
Propylene Glycol, Cetearyl Alcohol, Glycerin, Sodium Lauryl Sulfate,
Isopropyl Palmitate, Sodium
Metabisulfite, Sorbic Acid, and Disodium EDTA.
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
which may be prevented by the broad spectrum sunscreen agents
contained in SunVanish.
III. INDICATIONS AND USAGE
SunVanish is indicated for the gradual bleaching 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. CAUTION: Hydroquinone is a skin bleaching agent which may produce
unwanted cosmetic effects
if not used as directed. The physician should be familiar with the
contents of this insert before
prescribing or dispensing this medication.
B. Test for skin sensitivity before using SunVanish by applying a
small amount to an unbroken patch of
skin and check in 24 hours. Minor redness is not a cont