CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE SURGICAL

CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE 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.

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 StructureChemical 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.

CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE SURGICAL 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 SYSTEM TRAVEL-SIZE SURGICAL

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 — Kit Carton

OBAGI ®
CONDITION & ENHANCE SYSTEM

For Use with Surgical Procedures

Travel Size

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
CONDITION AND ENHANCE GENTLE CLEANSER Cleansing (cold creams, cleansing lotions, liquids, and pads)
CONDITION AND ENHANCE TONER Face and Neck (excluding shaving preparations)
CONDITION AND ENHANCE EXFODERM Face and Neck (excluding shaving preparations)
CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE SURGICAL
hydroquinone, octinoxate and zinc oxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-508
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-508-04 1 KIT (KIT) in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 28.5 g
Part 2 1 BOTTLE, PLASTIC 57 g
Part 3 1 BOTTLE, PLASTIC 30 mL
Part 4 1 BOTTLE, PLASTIC 60 mL
Part 5 1 BOTTLE, PLASTIC 60 mL
Part 6 1 BOTTLE, PLASTIC 57 g
Part 7 1 BOTTLE, PLASTIC 28.5 g
Part 1 of 7
CONDITION AND ENHANCE BLENDER SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
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
PPG-2 MYRISTYL ETHER PROPIONATE
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
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1988
Part 2 of 7
CONDITION AND ENHANCE CLEAR SKIN BLEACHING AND CORRECTOR
hydroquinone cream
Product Information
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
Part 3 of 7
CONDITION AND ENHANCE HEALTHY SKIN PROTECTION SPF 35
octinoxate and zinc oxide cream
Product Information
Item Code (Source) NDC:62032-119
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 90 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL PALMITATE
WATER
ETHYLHEXYL STEARATE
CETOSTEARYL ALCOHOL
POLYSORBATE 60
C13-14 ISOPARAFFIN
METHYLPARABEN
LAURETH-7
PROPYLPARABEN
EDETATE DISODIUM
BUTYLPARABEN
DIETHANOLAMINE CETYL PHOSPHATE
PHENOXYETHANOL
ETHYLPARABEN
ISOBUTYLPARABEN
SODIUM HYDROXIDE
TRIETHOXYCAPRYLYLSILANE
CITRIC ACID MONOHYDRATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-119-10 30 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2002
Part 4 of 7
CONDITION AND ENHANCE GENTLE CLEANSER
inert liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
PHENOXYETHANOL
METHYLPARABEN
PROPYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
ISOBUTYLPARABEN
SODIUM LAUROYL OAT AMINO ACIDS
COCAMIDOPROPYL BETAINE
SODIUM LAURETH SULFATE
ALOE VERA LEAF
GLYCERETH-7
PANTHENOL
DIETHYLENE GLYCOL MONOETHYL ETHER
TROLAMINE
SAGE
FD&C YELLOW NO. 5
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
APRICOT KERNEL OIL
Product Characteristics
Color YELLOW Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/1988
Part 5 of 7
CONDITION AND ENHANCE TONER
inert liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
SODIUM PYRROLIDONE CARBOXYLATE
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
POTASSIUM ALUM
PANTHENOL
SAGE
CALENDULA OFFICINALIS FLOWER
POLYSORBATE 80
ALLANTOIN
ALOE VERA LEAF
FD&C BLUE NO. 1
HAMAMELIS VIRGINIANA TOP WATER
Product Characteristics
Color BLUE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/1988
Part 6 of 7
CONDITION AND ENHANCE PHYSICAL UV BLOCK SPF 32
zinc oxide cream
Product Information
Item Code (Source) NDC:62032-118
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 185 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL PALMITATE
WATER
ETHYLHEXYL STEARATE
HYDROGENATED CASTOR OIL
YELLOW WAX
GLYCERETH-26
SODIUM CHLORIDE
METHYLPARABEN
DIMETHICONE
PROPYLPARABEN
EDETATE DISODIUM
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
BUTYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
TRIETHOXYCAPRYLYLSILANE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-118-36 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2004
Part 7 of 7
CONDITION AND ENHANCE EXFODERM
inert lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
POLYSORBATE 60
CETOSTEARYL ALCOHOL
STEARETH-20
CANOLA OIL
ISOHEXADECANE
MAGNESIUM ALUMINUM SILICATE
CETYL ALCOHOL
FYTIC ACID
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
DIMETHICONE
PEG-150 STEARATE
PHENOXYETHANOL
BUTYLPARABEN
ETHYLPARABEN
ISOBUTYLPARABEN
POTASSIUM CETYL PHOSPHATE
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE
GLYCERETH-7
DIETHYLENE GLYCOL MONOETHYL ETHER
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 28.5 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/1988
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/20/2007
Labeler — OMP, INC. (790553353)
Establishment
Name Address ID/FEI Operations
PURETEK CORPORATION 785961046 MANUFACTURE (62032-508), LABEL (62032-508), PACK (62032-508)
Establishment
Name Address ID/FEI Operations
Ei INC. 105803274 MANUFACTURE (62032-508), LABEL (62032-508), PACK (62032-508), ANALYSIS (62032-508)
Establishment
Name Address ID/FEI Operations
Swiss-American Products 611921669 MANUFACTURE (62032-508)
Establishment
Name Address ID/FEI Operations
Bay Cities Container Corporation 066229618 RELABEL (62032-508), REPACK (62032-508)

Revised: 05/2012 OMP, INC.

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