Drugplain

OBAGI C RX system C CLARIFYING SERUM 40 mg/mL

HYDROQUINONE · SOLUTION · Obagi Cosmeceuticals LLC

No Recall History
Plain English

OBAGI C RX system C CLARIFYING SERUM is a solution containing hydroquinone at 40 mg/mL, taken topical. Manufactured by Obagi Cosmeceuticals LLC.

Key Facts

Brand Name
OBAGI C RX system C CLARIFYING SERUM
Generic Name
HYDROQUINONE
NDC Code (Product)
62032-106
Manufacturer
Obagi Cosmeceuticals LLC
Strength
40 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Drug Class
Melanin Synthesis Inhibitor [EPC]
Marketing Start
01/01/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

squamous cell carcinoma of skin44 reports
drug ineffective43 reports
fatigue43 reports
pain41 reports
pruritus35 reports
product use in unapproved indication34 reports
off label use32 reports
condition aggravated31 reports
anxiety30 reports
arthralgia27 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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

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 a…

Contraindications

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.

Adverse Reactions

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.

Frequently Asked Questions

What is OBAGI C RX system C CLARIFYING SERUM used for?

OBAGI C RX system C CLARIFYING SERUM contains HYDROQUINONE. It is a solution taken topical. Consult your doctor for specific uses.

Is OBAGI C RX system C CLARIFYING SERUM a controlled substance?

OBAGI C RX system C CLARIFYING SERUM is not classified as a controlled substance by the DEA.

What is the generic name for OBAGI C RX system C CLARIFYING SERUM?

The generic name for OBAGI C RX system C CLARIFYING SERUM is HYDROQUINONE. There are 12 other brand versions of HYDROQUINONE.

What is the NDC code for OBAGI C RX system C CLARIFYING SERUM 40 mg/mL?

The NDC (National Drug Code) for OBAGI C RX system C CLARIFYING SERUM 40 mg/mL is 62032-106, listed by Obagi Cosmeceuticals LLC.

Product NDC

62032-106

Package NDC

62032-106-10

Other Hydroquinone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)