Obagi-C Rx System

Name: Obagi-C Rx System

Physician prescribing information

Rx only

FOR EXTERNAL USE ONLY

-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

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.

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.

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