OBAGI-C RX SYSTEM C-THERAPY NIGHT- hydroquinone cream
OBAGI-C RX system C-THERAPY by
Drug Labeling and Warnings
OBAGI-C RX system C-THERAPY by is a Prescription medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, VALEANT PHARMACEUTICALS NORTH AMERICA LLC, G.S. COSMECEUTICAL USA, INC., PURETEK CORPORATION. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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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
- 62032-106-10 Obagi-C® Rx System C-Clarifying Serum for Normal to Dry Skin
- 62032-122-10 Obagi-C® Rx System C-Clarifying Serum for Normal to Oily Skin
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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
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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.
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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
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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.
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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.
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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.
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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
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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: 62032-106-10Obagi-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: 62032-122-10Obagi-C® Rx System C-Therapy Night Cream
(Hydroquinone, USP 4%) is available as follows:
Net wt. 2 oz. (57 g) bottle
NDC: 62032-105-36Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.
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- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
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INGREDIENTS AND APPEARANCE
OBAGI-C RX SYSTEM C-THERAPY NIGHT
hydroquinone creamProduct 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 - Obagi Cosmeceuticals LLC (790553353) Registrant - VALEANT PHARMACEUTICALS NORTH AMERICA LLC (042230623) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(62032-105) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-105) , LABEL(62032-105) , PACK(62032-105)
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