GLYTONE SUNVANISH SKIN LIGHTENING- hydroquinone cream

Glytone SunVanish Skin Lightening by

Drug Labeling and Warnings

Glytone SunVanish Skin Lightening by is a Prescription medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 6H 6O 2 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 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, 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 asthmatic than in nonasthmatic people.

B. May produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of treatment.

C. Sunscreen use is an essential aspect of hydroquinone therapy because minimal sunlight sustains melanocytic activity. The sunscreen agents in Glytone SunVanish provide sun protection during skin lightening therapy. During the day, supplement therapy by using an effective broad spectrum sunscreen and avoiding unnecessary sun exposure, or wear sun-protective clothing to cover treated areas in order to prevent repigmentation from occurring.

VI. PRECAUTIONS

See WARNINGS

A. Test for skin sensitivity before using Glytone SunVanish by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Hydroquinone is a skin lightening 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. Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with warm water and contact a physician.

C. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

D. Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should not be used on pregnant women.

E. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers.

F. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age.

VII. ADVERSE REACTIONS

No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.

Sensitivity to sodium metabisulfite is a potential. See WARNINGS.

VIII. OVERDOSAGE

There have been no systemic reactions from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment, but indicates caution is warranted.

IX. DRUG DOSAGE AND ADMINISTRATION

Glytone SunVanish should be applied daily in the morning to affected areas and rubbed in well, or as directed by a physician. If no lightening effect is seen after 2 months of treatment, use of this product should be discontinued.

Limit sunlight exposure during the day by applying an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing to cover treated areas.

X. HOW SUPPLIED

SunVanish is available as follows:

SizeNDC 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

PRINCIPAL DISPLAY - GLYTONE SunVanish Carton 56 g

NDC: 64760-702-01

GLYTONE

SunVanish

Skin Lightening

Cream

Broad Spectrum Sunscreen SPF 25

BRIGHTENING

4% Hydroquinone, USP

Rx Only

NET WT. 56.7 g / 2 OZ.

INGREDIENTS AND APPEARANCE

GLYTONE SUNVANISH SKIN LIGHTENING 
hydroquinone cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64760-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	18.6 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-702-01	1 in 1 CARTON	03/14/2018
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/13/2012

Labeler - Pierre Fabre USA Inc. (117196928)