Document

DailyMed Label: OBAGI-C RX system NORMAL-oily

Title
DailyMed Label: OBAGI-C RX system NORMAL-oily
Date
2023
Document type
DailyMed Prescription
Name
OBAGI-C RX system NORMAL-oily
Generic name
HYDROQUINONE, HOMOSALATE, OCTISALATE AND ZINC OXIDE
Manufacturer
Obagi Cosmeceuticals LLC
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
Product information
NDC: 62032-534
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 C 6 H 6 O 2 ; molecular weight is 110.11 g per mol. The chemical structure is in the diagram. Chemical Structure
Indications
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Dosage
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.
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.
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. 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. 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.
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.
How supplied
(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 (Hydroquinone, USP 4%) is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-105-36 Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.
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.
Patient information
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.
Package label
NDC# 62032-534-04 OBAGI ® MEDICAL OBAGI-C ® RX SYSTEM NORMAL OILY Skin Intervention Kit PRINCIPAL DISPLAY PANEL - Kit Carton

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