GLYTONE SUNVANISH SKIN LIGHTENING- hydroquinone cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Verfügbar ab:

Pierre Fabre USA Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Glytone SunVanish 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.

Produktbesonderheiten:

SunVanish is available as follows: Size NDC Number Net Wt. 2 Oz. / 56 g tube 64760-702-01 SunVanish should be stored at controlled room temperature 15° - 30° C (59° - 86° F). Do not expose to heat above 86° F or direct sunlight. Distributed by: Pierre Fabre USA, Inc. Parsippany, NJ 07054 Made in U.S.A. 1-800-GLYTONE (459-8663) www.glytone.com Rev. 121118

Berechtigungsstatus:

unapproved drug other

Fachinformation

GLYTONE SUNVANISH 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 CLARIFYING SUNVANISH WITH SUNSCREEN
GLYTONE SUNVANISH
HYDROQUINONE USP, 4%
SKIN LIGHTENING CREAM
WITH BROAD SPECTRUM SPF 25
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
I. DESCRIPTION
Each gram of Glytone SunVanish (Hydroquinone USP, 4%) Skin Lightening
Cream with Broad
Spectrum SPF 25 contains 40 mg of Hydroquinone USP with 20 mg of
Avobenzone, 75 mg of
Octinoxate, 18.6 mg of Octocrylene, and 50 mg Oxybenzone in a cream
base of Cetearyl Alcohol,
Glycerin, Edetate Disodium, Isopropyl Palmitate, Propylene Glycol,
Purified Water, Sodium Lauryl
Sulfate, Sodium Metabisulfite, 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
which may be prevented by the broad spectrum sunscreen agents
contained in SunVanish.
III. INDICATIONS AND USAGE
Glytone SunVanish 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
6
6
2
topical hydroquinone use during pregnancy or in children (12 years and
under) has not been established.
V. WARNINGS
A. Contains sodium metabisulfite, a sulfite that may cause
allergic-type reactions (e.g. hives, it