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Skin Lightening Complex

Generic Name: hydroquinone
Dosage Form: cream

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.

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.

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Skin Lightening Complex 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.

Skin Lightening Complex - 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 Skin Lightening Complex

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.

Skin Lightening Complex 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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:62032-120-60 57 g in 1 TUBE
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: 02/2011
 
Obagi Medical Products, Inc.



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