Obagi-c®

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

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 or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

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.

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

To report SUSPECTED ADVERSE REACTIONS, contact Obagi Medical Products, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Obagi-C^® Rx System C-Clarifying Serum

(Hydroquinone, USP 4%) for Normal to Dry Skin is available as follows:

1 fl. oz. (30 mL) bottle    

NDC 62032-106-10

Obagi-C^® Rx System C-Clarifying Serum

(Hydroquinone, USP 4%) for Normal to Oily Skin is available as follows:

1 fl. oz. (30 mL) bottle    

NDC 62032-122-10

Obagi-C^® Rx System C-Therapy Night Cream

(Hydroquinone, USP 4%) is available as follows:

Net wt. 2 oz. (57 g) bottle    

NDC 62032-105-36

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

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.

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 C6H6O2; molecular weight is 110.11 g per mol.

The chemical structure is in the diagram.

WELCOME TO THE OBAGI-C^® RX SYSTEM OF SKIN CARE PRODUCTS!

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

• Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, the 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.

The Obagi-C® Rx System C-Therapy Night Cream 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.

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.

(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.

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.

Safety and effectiveness in children, below the age of 12 years, have not been established.

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 sunscreen agents contained in the Obagi-C® Rx System Sun Shield Matte Broad Spectrum SPF 50.

Each gram of Obagi-C^® Rx System C-Therapy Night Cream contains:

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

Inactives: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, TEA-salicylate, tocopheryl acetate, water

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

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

Rx only

FOR EXTERNAL USE ONLY

OBAGI-C^®

RX SYSTEM

NDC# 62032-122-10

• NON-COMEDOGENIC

NON-ACNEGENIC •

C-CLARIFYING SERUM

SKIN LIGHTENING SERUM

WITH VITAMIN C 10%

HYDROQUINONE USP, 4%

RX ONLY

FOR NORMAL TO OILY SKIN

AM

1 fl. oz. (30 mL)

WELCOME TO THE OBAGI-C^® RX SYSTEM OF SKIN CARE PRODUCTS!

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

• Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, the 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.

The Obagi-C® Rx System C-Therapy Night Cream 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.

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.

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 C6H6O2; molecular weight is 110.11 g per mol.

The chemical structure is in the diagram.

(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.

Obagi-C^® Rx System C-Clarifying Serum

(Hydroquinone, USP 4%) for Normal to Dry Skin is available as follows:

1 fl. oz. (30 mL) bottle    

NDC 62032-106-10

Obagi-C^® Rx System C-Clarifying Serum

(Hydroquinone, USP 4%) for Normal to Oily Skin is available as follows:

1 fl. oz. (30 mL) bottle    

NDC 62032-122-10

Obagi-C^® Rx System C-Therapy Night Cream

(Hydroquinone, USP 4%) is available as follows:

Net wt. 2 oz. (57 g) bottle    

NDC 62032-105-36

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

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.

Safety and effectiveness in children, below the age of 12 years, have not been established.

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

To report SUSPECTED ADVERSE REACTIONS, contact Obagi Medical Products, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

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.

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 sunscreen agents contained in the Obagi-C® Rx System Sun Shield Matte Broad Spectrum SPF 50.

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

Each gram of Obagi-C^® Rx System C-Therapy Night Cream contains:

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

Inactives: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, TEA-salicylate, tocopheryl acetate, water

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

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

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 or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Rx only

FOR EXTERNAL USE ONLY

OBAGI-C^®

RX SYSTEM

NDC# 62032-122-10

• NON-COMEDOGENIC

NON-ACNEGENIC •

C-CLARIFYING SERUM

SKIN LIGHTENING SERUM

WITH VITAMIN C 10%

HYDROQUINONE USP, 4%

RX ONLY

FOR NORMAL TO OILY SKIN

AM

1 fl. oz. (30 mL)