Obag Nu-Derm Clear

Generic Name: hydroquinone
Dosage Form: cream, 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 Nu-Derm® Clear
(Hydroquinone USP, 4%) Skin Bleaching Cream

Obagi Nu-Derm Blender®
(Hydroquinone USP, 4%)
Skin Bleaching Cream

Obagi Nu-Derm Sunfader®
(Hydroquinone USP, 4%; Octinoxate USP, 7.5%;
Oxybenzone USP, 5.5%)
Skin Bleaching Cream with Sunscreens

Rx Only

For external use only

Obag Nu-Derm Clear Description

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

Each gram of Obagi Nu-Derm Clear contains:

Active ingredient: Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben

Each gram of Obagi Nu-Derm Blender contains:

Active ingredient: Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients: 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, disodium EDTA, propylparaben, saponins, BHT

Each gram of Obagi Nu-Derm Sunfader contains:

Active ingredients: Hydroquinone USP, 4% (40 mg/g); Octinoxate USP, 7.5%; Oxybenzone USP, 5.5%

Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, saponins, propylparaben, butylparaben

Obag Nu-Derm Clear - 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 Nu-Derm Sunfader and Obagi Nu-Derm Sun Shield Matte Broad Spectrum SPF 50.

Indications and Usage for Obag Nu-Derm Clear

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.

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 product.

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, product should be discontinued and physician consulted. Close patient supervision is recommended.

Warnings: Avoid contact with eyes, nose, mouth, and lips.In case of accidental contact, patient should rinse thoroughly 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.

Obag Nu-Derm Clear Dosage and Administration

A thin application should be applied once or 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 sunblocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

How is Obag Nu-Derm Clear Supplied

Obagi Nu-Derm Clear is available as follows:

Net wt. 2 oz. (57 g) bottle
NDC 62032-101-36

Obagi Nu-Derm Blender is available as follows:

Net wt. 2 oz. (57 g) bottle
NDC 62032-100-36

Net wt. 1 oz. (28 g) bottle
NDC 62032-100-10

Obagi Nu-Derm Sunfader is available as follows:

Net wt. 2 oz. (57 g) bottle
NDC 62032-116-36

Store at controlled room temperature: 15°C-25°C (59°F-77°F). Keep out of direct sunlight.

Blender, Obagi Nu-Derm, and Sunfader are registered trademarks of OMP, Inc.

Distributed by OMP, Inc.
Long Beach, CA 90806

1-800-636-7546

©2012 Obagi Medical Products, Inc.

All rights reserved.

www.obagi.com Made in USA

30700311Z Rev. 09/12

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

OBAGI
NU-DERM ®

NDC 62032-101-36

AM CLEAR
PM

3

SKIN BLEACHING
& CORRECTOR CREAM

HYDROQUINONE USP, 4%
Rx ONLY

Net wt. 2 oz. (57g)

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

OBAGI
NU-DERM ®

NDC 62032-100-36

BLENDER®

PM

5

SKIN LIGHTENER
& BLENDING CREAM

HYDROQUINONE USP, 4%
Rx ONLY

Net wt. 2 oz. (57g)

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

OBAGI
NU-DERM ®

NDC 62032-116-36

AM SUNFADER®

6

SKIN LIGHTENER
WITH SUNSCREEN
(SPF 15) PABA FREE

HYDROQUINONE USP, 4%
Rx ONLY

NET WT. 2 OZ. (57g)

NU-DERM CLEAR  SKIN BLEACHING AND CORRECTOR
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-101
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
WATER  
CETYL ALCOHOL  
GLYCERIN  
SODIUM LAURYL SULFATE  
STEARYL ALCOHOL  
LACTIC ACID  
.ALPHA.-TOCOPHEROL ACETATE  
ASCORBIC ACID  
SODIUM METABISULFITE  
EDETATE DISODIUM  
METHYLPARABEN  
BUTYLATED HYDROXYTOLUENE  
PROPYLPARABEN  
BUTYLPARABEN  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:62032-101-36 57 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1988
NU-DERM BLENDER  SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-100
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
WATER  
GLYCERIN  
CETYL ALCOHOL  
PPG-2 MYRISTYL ETHER PROPIONATE  
SODIUM LAURYL SULFATE  
TROLAMINE SALICYLATE  
LACTIC ACID  
PHENYL TRIMETHICONE  
.ALPHA.-TOCOPHEROL ACETATE  
SODIUM METABISULFITE  
ASCORBIC ACID  
METHYLPARABEN  
EDETATE DISODIUM  
PROPYLPARABEN  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:62032-100-10 28.5 g in 1 BOTTLE, PLASTIC
2 NDC:62032-100-36 57 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1988
NU-DERM SUNFADER  SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA FREE
hydroquinone, octinoxate, and oxybenzone lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-116
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg  in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 55 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
CETYL ALCOHOL  
GLYCERIN  
SODIUM LAURYL SULFATE  
STEARYL ALCOHOL  
.ALPHA.-TOCOPHEROL ACETATE  
ASCORBIC ACID  
SODIUM METABISULFITE  
EDETATE DISODIUM  
METHYLPARABEN  
BUTYLATED HYDROXYTOLUENE  
PROPYLPARABEN  
BUTYLPARABEN  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:62032-116-36 57 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1984
Labeler - OMP, INC. (790553353)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 MANUFACTURE(62032-101, 62032-100, 62032-116), LABEL(62032-101, 62032-100, 62032-116), PACK(62032-101, 62032-100, 62032-116)
Establishment
Name Address ID/FEI Operations
Ei LLC 105803274 MANUFACTURE(62032-101, 62032-100, 62032-116), LABEL(62032-101, 62032-100, 62032-116), PACK(62032-101, 62032-100, 62032-116), ANALYSIS(62032-101, 62032-100, 62032-116)
Revised: 06/2014
 
OMP, INC.
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