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Obagi Cosmeceuticals LLC
Dosage Form
N/A
Manufacturer
Obagi Cosmeceuticals LLC
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
When using this product keep out of eyes. Rinse with water to remove.
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
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.
Do not use on damaged or broken skin
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.
Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.
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.
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.
[image: MM1]NDC# 62032-535-04
OBAGI®
MEDICAL
OBAGI-C® RX SYSTEM
NORMAL DRY
Skin Intervention Kit
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
Photos of the product and/or packaging supplied by the manufacturer.
WELCOME TO THE OBAGI-C® Rx SYSTEM OF SKIN CARE PRODUCTS!
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
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.
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.
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
Drug Facts
Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806
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