Obagi C Rx System C Therapy Night

Name: Obagi C Rx System C Therapy Night

Patient information

For Topical Use Only

Complete skin care regimen formulated with 4% hydroquinone to reduce hyperpigmentation and other essential ingredients to help address the signs of skin aging caused by photoaging.

Please read this product information prior to use of the Obagi-C® Rx System. Any questions regarding your particular skin care regimen should be directed to your physician. More information about the Obagi-C® Rx System or other Obagi systems is available at our website at www.obagi.com.

-106-10 Obagi-C® Rx System C-Clarifying Serum for Normal to Dry Skin

Each gram of Obagi-C® Rx System C-Clarifying Serum for Normal to Dry Skin contains:

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

Inactives:ascorbic acid, propylene carbonate, propylene glycol, sodium lauryl sulfate, water

-122-10 Obagi-C® Rx System C-Clarifying Serum for Normal to Oily Skin

Each gram of Obagi-C® Rx System C-Clarifying Serum for Normal to Oily Skin contains:

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

Inactives:ascorbic acid, dipropylene glycol, fragrance, propylene carbonate, propylene glycol, SD alcohol-39-C, sodium lauryl sulfate, water

Precautions

(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

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.

Principal display panel c-therapy night cream

OBAGI-C® RX SYSTEM

NDC# 62032-105-36

C-THERAPY NIGHT CREAM

SKIN LIGHTENING CREAM
WITH VITAMIN C & E
HYDROQUINONE USP, 4%
RX ONLY

PM

Net wt. 2 oz. (57 g)

OBAGI-C RX SYSTEM C-THERAPY  NIGHT
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-105
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, UNSPECIFIED FORM  
METHYLPARABEN  
PHENYL TRIMETHICONE  
PPG-2 MYRISTYL ETHER PROPIONATE  
PROPYLPARABEN  
SODIUM LAURYL SULFATE  
SODIUM METABISULFITE  
TROLAMINE SALICYLATE  
.ALPHA.-TOCOPHEROL ACETATE  
WATER  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:62032-105-36 57 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2010
Labeler - OMP, INC. (790553353)
Registrant - VALEANT PHARMACEUTICALS NORTH AMERICA LLC (042230623)
Establishment
Name Address ID/FEI Operations
Ei LLC 105803274 MANUFACTURE(62032-105)
Revised: 10/2016   OMP, INC.

For Healthcare Professionals

Applies to hydroquinone topical: compounding powder, topical cream, topical emulsion, topical gel, topical solution

Dermatologic

Dermatologic side effects have included localized contact dermatitis. Exogenous ochronosis (involving over 10,000 exposures under careful clinical supervision) has been reported at an incidence of 22 cases in more than 50 years.[Ref]

Some side effects of Obagi-C Rx System C-Therapy Night Cream may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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