OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION- hydroquinone, homosalate, octisalate and zinc oxide
Obagi Cosmeceuticals LLC
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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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 on our website at www.obagi.com.
Rx only
FOR EXTERNAL USE ONLY
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
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 metabisulfate, TEA-salicylate, tocopheryl acetate, water
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.
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.
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.
The Obagi-C® Rx System C-Therapy Night Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and lifethreatening 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.
(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.
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.
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 Cosmeceuticals LLC, at 1-800-636-7546 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.
(Hydroquinone, USP 4%) for Normal to Dry Skin is available as follows:
1 fl. oz. (30 mL) bottle
NDC 62032-106-10
(Hydroquinone, USP 4%) for Normal to Oily Skin is available as follows:
1 fl. oz. (30 mL) bottle
NDC 62032-122-10
Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806
U.S. Patent 6,299,889
All products/brand names, whether designated by notice or not (®/TM), are trademarks of Obagi Cosmeceuticals LLC and/or its affiliates.
©2019 Obagi Cosmeceuticals LLC.
All rights reserved.
www.obagi.com
9578903 Revised: 1/2019
Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone
OBAGI-C RX SYSTEM NORMAL-OILY
SKIN INTERVENTION
hydroquinone, homosalate, octisalate and zinc oxide kit |
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Labeler - Obagi Cosmeceuticals LLC (790553353) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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G. S. Cosmeceutical USA, Inc. | 017014734 | MANUFACTURE(62032-534) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Swiss American CDMO, LLC | 080170933 | MANUFACTURE(62032-534) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Universal Packaging Systems, Inc. (DBA Paklab) | 177711082 | MANUFACTURE(62032-534) , PACK(62032-534) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
PURETEK CORPORATION | 785961046 | MANUFACTURE(62032-534) , LABEL(62032-534) , PACK(62032-534) |