Obagi Skin Lightening Complex

Generic Name: hydroquinone
Dosage Form: lotion

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.

Obagi® Skin Lightening Complex
(Hydroquinone USP, 4%)
Skin Bleaching Cream

Rx Only
FOR EXTERNAL USE ONLY

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.

Slideshow: 2013 Drug News Round-Up: Top 20 Stories

Obagi 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 the diagram to the right.

Obagi 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 Obagi 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.

Obagi 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.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. 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.

Precautions

(ALSO SEE WARNINGS)

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.

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 be used on pregnant women only when clearly indicated.

NURSING MOTHERS

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

PEDIATRIC USAGE

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

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

How is Obagi Skin Lightening Complex Supplied

Obagi Skin Lightening Complex is available as follows:

2.0 oz (57 g) tube
NDC 63032-120-60

Store at controlled room temperature:
15°-25°C (59°F-77°F)

OBAGI®
MEDICAL

Obagi is a registered trademark of OMP, Inc.
Distributed by OMP, Inc.
Obagi Medical Products, Inc.
Long Beach, CA 90806
USA
www.obagi.com
60650611X

PRINCIPAL DISPLAY PANEL - 57 g Carton

NDC 62032-120-60

OBAGI®
MEDICAL

ELASTIderm®
décolletage

Chest and Neck

Skin
Lightening
Complex

Hydroquinone USP, 4%
Rx Only

NET WT 2.0 OZ. (57 g)

ELASTIDERM DECOLLETAGE SKIN LIGHTENING COMPLEX   CHEST AND NECK
hydroquinone lotion
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
EDETATE DISODIUM  
TROLAMINE SALICYLATE  
SODIUM LAURYL SULFATE  
CETYL ALCOHOL  
GLYCERIN  
LACTIC ACID  
ALPHA-TOCOPHEROL ACETATE  
ASCORBIC ACID  
SODIUM METABISULFITE  
WATER  
METHYLPARABEN  
PROPYLPARABEN  
BUTYLATED HYDROXYTOLUENE  
PHENYL TRIMETHICONE  
Product Characteristics
Color GRAY Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:62032-120-60 1 TUBE (TUBE) in 1 CARTON
1 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 - OMP, INC. (790553353)
Establishment
Name Address ID/FEI Operations
PURETEK CORPORATION 785961046 MANUFACTURE(62032-120), LABEL(62032-120), PACK(62032-120)
Revised: 12/2011
 
OMP, INC.
Hide
(web4)