CONDITION AND ENHANCE SYSTEM  TRAVEL-SIZE NON-SURGICAL- hydroquinone, octinoxate, and zinc oxide 
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.

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Obagi® Condition & Enhance Clear
(Hydroquinone USP, 4%)
Skin Bleaching Cream

Obagi® Condition & Enhance Blender®
(Hydroquinone USP, 4%)
Skin Bleaching Cream

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.

Chemical Structure

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.

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

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) bottleNDC 62032-115-36
1 oz. (28.5 gm) bottleNDC 62032-115-10

Obagi Condition and Enhance Clear is available as follows:

2 oz. (57 gm) bottleNDC 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 - Kit Carton

OBAGI®
CONDITION & ENHANCE SYSTEM
For Use with Nonsurgical Procedures

Travel Size

PRINCIPAL DISPLAY PANEL - Kit Carton
CONDITION AND ENHANCE SYSTEM   TRAVEL-SIZE NON-SURGICAL
hydroquinone, octinoxate, and zinc oxide kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62032-510
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-510-601 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 28.5 g
Part 21 BOTTLE, PLASTIC 57 g
Part 31 BOTTLE, PLASTIC 30 mL
Part 41 BOTTLE, PLASTIC 60 mL
Part 51 BOTTLE, PLASTIC 60 mL
Part 61 BOTTLE, PLASTIC 28.5 g
Part 1 of 6
CONDITION AND ENHANCE BLENDER   SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-115-1028.5 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1988
Part 2 of 6
CONDITION AND ENHANCE CLEAR   SKIN BLEACHING AND CORRECTOR
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-117-3657 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1988
Part 3 of 6
CONDITION AND ENHANCE HEALTHY SKIN PROTECTION  SPF 35
octinoxate and zinc oxide cream
Product Information
Item Code (Source)NDC:62032-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LAURETH-7 (UNII: Z95S6G8201)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-119-1030 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2002
Part 4 of 6
CONDITION AND ENHANCE FOAMING 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRALFALFA (UNII: DJO934BRBD)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/01/1988
Part 5 of 6
CONDITION AND ENHANCE TONER 
face and neck (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSAGE (UNII: 065C5D077J)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/01/1988
Part 6 of 6
CONDITION AND ENHANCE EXFODERM FORTE 
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGREMU OIL (UNII: 344821WD61)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
128.5 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/01/1988
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER08/20/2007
Labeler - OMP, INC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
PURETEK CORPORATION785961046MANUFACTURE(62032-510) , LABEL(62032-510) , PACK(62032-510)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-510) , LABEL(62032-510) , PACK(62032-510) , ANALYSIS(62032-510)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American Products611921669MANUFACTURE(62032-510)
Establishment
NameAddressID/FEIBusiness Operations
Bay Cities Container Corporation066229618RELABEL(62032-510) , REPACK(62032-510)

Revised: 5/2012
Document Id: 5a4e3679-60da-4c02-b325-5b7aafafb375
Set id: 5d843214-4ede-4bd5-a919-c8faca9ccade
Version: 1
Effective Time: 20120510
 
OMP, INC.