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OBAGI-C RX SYSTEM C-THERAPY (OMP, INC.)

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CREAM 57 g in 1 BOTTLE, PLASTIC (62032-105-36) Label Information

Complete OBAGI-C RX SYSTEM C-THERAPY Information

  • SPL UNCLASSIFIED SECTION

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


  • 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.


  • PHYSICIAN PRESCRIBING INFORMATION

    Rx only

    FOR EXTERNAL USE ONLY


  • 62032-106-10 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


  • 62032-122-10 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


  • 62032-105-36 Obagi-C® Rx System C-Therapy Night Cream

    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


  • 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 C6H6O2; molecular weight is 110.11 g per mol.

    The chemical structure is in the diagram.

    chemstructure

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


  • INDICATIONS AND USAGE

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


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


  • 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, 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.


  • 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.


  • 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 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.


  • 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.


  • HOW SUPPLIED

    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.


  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC
    Bridgewater, NJ 08807 USA

    U.S. Patent 6,299,889

    Obagi-C is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

    ©OMP, Inc.

    www.obagi.com

    9578901

    Revised: 10/2016


  • 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)

    C-Therapy Night Cream

  • INGREDIENTS AND APPEARANCE
    OBAGI-C RX SYSTEM C-THERAPY  NIGHT
    hydroquinone cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-105
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62032-105-36 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2010
    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 Business Operations
    Ei LLC 105803274 MANUFACTURE(62032-105)