Skin Lightening Complex

hydroquinone

Dosage Form: cream
Elastiderm Decolletage Kit

Rx Only

FOR EXTERNAL USE ONLY

Obagi® Skin Lightening Complex

(Hydroquinone USP, 4%)

Skin Bleaching Cream

ACTIVE INGREDIENTS

Each gram of Skin Lightening Complex contains Hydroquinone USP 40 mg/g in a base of Ascorbic Acid, BHT, Cetyl Alcohol, Disodium EDTA, Glycerin, Lactic Acid, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Saponins, Sodium Lauryl Sulfate, Sodium Metabisulfite, TEA-Salicylate, Tocopheryl Acetate and Water.

DESCRIPTION

Hydroquinone is 1,4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; the molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.

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 bleached areas, which may be prevented by the use of sunblocking agents or sunscreen agents.

INDICATIONS AND USAGE

For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

CONTRAINDICATIONS

People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

DOSAGE AND ADMINISTRATION

A thin application should be applied to the chest and neck area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sunblocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.

WARNINGS

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.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, the product should be discontinued and a physician consulted. Close patient supervision is recommended.

Avoid contact with the eyes, nose, mouth, or lips. In case of accidental contact, the patient should rinse the eyes, nose, mouth, or lips with water and contact a physician.

Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

INACTIVE INGREDIENTS

Ascorbic Acid, BHT, Cetyl Alcohol, Disodium EDTA, Glycerin, Lactic Acid, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Saponins, Sodium Lauryl Sulfate, Sodium Metabisulfite, TEA-Salicylate, Tocopheryl Acetate and Water.

PRINCIPAL DISPLAY PANEL

NDC 62032-120-60

OBAGI® MEDICAL

ELASTIderm® décolletage

Chest and Neck

Skin Lightening Complex

Hydroquinone USP, 4%

Rx Only

Skin Lightening Complex  hydroquinone  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 62032-120 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg  in 1 g

Inactive Ingredients Ingredient Name Strength ASCORBIC ACID   BUTYLATED HYDROXYTOLUENE   CETYL ALCOHOL   EDETATE DISODIUM   GLYCERIN   LACTIC ACID   METHYLPARABEN   PHENYL TRIMETHICONE   SODIUM LAURYL SULFATE   SODIUM METABISULFITE   .ALPHA.-TOCOPHEROL ACETATE, D-   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 62032-120-60 57 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/01/2010

Labeler - Obagi Medical Products, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Operations
PureTek Corporation		785961046	MANUFACTURE

Revised: 02/2011Obagi Medical Products, Inc.

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