CONDITION AND ENHANCE CLEAR Skin Bleaching and Corrector

CONDITION AND ENHANCE CLEAR SKIN BLEACHING AND CORRECTOR- hydroquinone cream
CONDITION AND ENHANCE BLENDER SKIN LIGHTENER AND BLENDING- hydroquinone cream
OMP, INC.

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.

Rx Only

FOR EXTERNAL USE ONLY

DESCRIPTION

Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C₆ H₆ O₂ ; molecular weight is 110.0.

Obagi^® Condition & Enhance Blender contains Hydroquinone USP 40 mg/gm in a base of purified water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, saponins, disodium EDTA, BHT, and propylparaben.

Obagi^® Condition & Enhance Clear contains Hydroquinone USP 40 mg/gm in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, lactic acid, saponins, disodium EDTA, methylparaben, BHT, propylparaben, and butylparaben.

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 contained in Obagi Condition & Enhance.

CONDITION AND ENHANCE CLEAR Skin Bleaching and Corrector Indications and Usage

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

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.

WARNINGS

Caution

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 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.

Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips.

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

Warning

Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons.

PRECAUTIONS

(SEE WARNINGS)

General

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 to CONDITION AND ENHANCE CLEAR Skin Bleaching and Corrector

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

DOSAGE AND ADMINISTRATION

A thin application should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.

HOW SUPPLIED

Obagi Condition and Enhance Blender is available as follows:

2 oz. (57 gm) bottle	NDC 62032-115-36
1 oz. (28.5 gm) bottle	NDC 62032-115-10

Obagi Condition and Enhance Clear is available as follows:

2 oz. (57 gm) bottle

NDC 62032-117-36

Store at 25°C (77°F); excursion permitted to 15°C-30°C (59°F-86°F).

OBAGI^®
MEDICAL

OMP, Inc.
Long Beach, CA 90802
USA
1-800-636-7546

80707910U Rev. 6/07

PRINCIPAL DISPLAY PANEL — 57 g Bottle Label

OBAGI^®
MEDICAL

CONDITION & ENHANCE

NDC 62032-117-36
AM • PM
3

clear

Skin Bleaching & Corrector Cream
Hydroquinone USP, 4%
Rx Only

NET WT. 2 OZ. (57 g)

PRINCIPAL DISPLAY PANEL — 57 g Bottle Label

OBAGI^®
MEDICAL

CONDITION & ENHANCE

NDC 62032-115-36
PM
5

blender^®

Skin Lightener & Blending Cream
Hydroquinone USP, 4%
Rx Only

NET WT. 2 OZ. (57 g)

CONDITION AND ENHANCE CLEAR SKIN BLEACHING AND CORRECTOR hydroquinone cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-117 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 BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62032-117-36 57 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1988

CONDITION AND ENHANCE BLENDER SKIN LIGHTENER AND BLENDING hydroquinone cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-115 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 WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62032-115-10 28.5 g in 1 BOTTLE, PLASTIC None 2 NDC:62032-115-36 57 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1988

Labeler — OMP, INC. (790553353)

Establishment
Name	Address	ID/FEI	Operations
PURETEK CORPORATION		785961046	MANUFACTURE (62032-117), MANUFACTURE (62032-115), LABEL (62032-117), LABEL (62032-115), PACK (62032-117), PACK (62032-115)

Establishment
Name	Address	ID/FEI	Operations
Ei INC.		105803274	MANUFACTURE (62032-117), MANUFACTURE (62032-115), LABEL (62032-117), LABEL (62032-115), PACK (62032-117), PACK (62032-115), ANALYSIS (62032-117), ANALYSIS (62032-115)

Revised: 12/2011 OMP, INC.