Hydroquinone
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.; PRINCIPAL DISPLAY PANEL - Kit Carton NDC# 62032-534-04 OBAGI ® MEDICAL OBAGI-C ® RX SYSTEM NORMAL OILY Skin Intervention Kit PRINCIPAL DISPLAY PANEL - Kit Carton
- HOW SUPPLIED 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 Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.
- PRINCIPAL DISPLAY PANEL - Kit Carton NDC# 62032-534-04 OBAGI ® MEDICAL OBAGI-C ® RX SYSTEM NORMAL OILY Skin Intervention Kit PRINCIPAL DISPLAY PANEL - Kit Carton
Overview
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 & Usage
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Dosage & 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. Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
Warnings & Precautions
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 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. Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
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.
Purpose
Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen
Do Not Use
Do not use on damaged or broken skin
When Using
When using this product keep out of eyes. Rinse with water to remove.
Stop Use & Ask a Doctor
Stop use and ask a doctor if rash occurs
Keep Out of Reach of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage & Handling
Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight. Other information store at controlled room temperature: 15°C–25°C (59°F–77°F) protect this product from excessive heat and direct sun
Questions
Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time
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