GLYTONE SKIN LIGHTENING- hydroquinone gel

Glytone Skin Lightening by

Drug Labeling and Warnings

Glytone 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

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 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 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 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. There are no sunscreen agents in Glytone Skin Lightening Gel. Since minimal sunlight exposure may reverse the lightening effect of this preparation, an effective broad spectrum sunscreen should be used during the day, and unnecessary sun exposure avoided, or sun-protective clothing should be worn to cover treated areas in order to prevent repigmentation from occurring.

For daytime lightening of unwanted hyperpigmented areas, Glytone SunVanish Skin Lightening Cream Broad Spectrum SPF 25 should be considered.

VI. PRECAUTIONS

See  WARNINGS

A. Test for skin sensitivity before using Glytone Skin Lightening Gel 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 in 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 bisulfite 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 Skin Lightening Gel should be applied daily at night 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.

During the day, avoid sunlight exposure to treated areas by using an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing.

X. HOW SUPPLIED

Glytone Hydroquinone USP, 4% Skin Lightening Gel is available as follows:

• Size: NDC Number
• NET WT. 2 OZ. / 56 g tube: 64760-701-01

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

PRINCIPAL DISPLAY PANEL

NDC: 64760-701-01

GLYTONE

Hydroquinone USP, 4%

Skin Lightening Gel

Rx Only

NET WT. 56 g / 2 OZ.

INGREDIENTS AND APPEARANCE

GLYTONE SKIN LIGHTENING 
hydroquinone gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64760-701
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SODIUM BISULFITE (UNII: TZX5469Z6I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBIC ACID (UNII: X045WJ989B)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-701-01	1 in 1 CARTON	04/01/2010
1		56 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2010

Labeler - Pierre Fabre USA Inc. (117196928)