Hydroquinone, Octisalate And Zinc Oxide

FDA Drug Information • Also known as: Nu-Derm System Normal-Dry Skin Transformation

Brand Names
Nu-Derm System Normal-Dry Skin Transformation
Dosage Form
KIT
Product Type
HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Hydroquinone, USP 4% is 1, 4-benzenediol. 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/mol. The chemical structure is in the diagram below. Chemical Structure Each gram of Obagi Nu-Derm ® Clear contains: ACTIVE: Hydroquinone, USP 4% (40 mg/g) INACTIVES: ascorbic acid, BHT, butylparaben, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tocopheryl acetate, water (aqua) Each gram of Obagi Nu-Derm Blender ® contains: ACTIVE: Hydroquinone, USP 4% (40 mg/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 metabisulfite, TEA-salicylate, tocopheryl acetate, water (aqua) Each gram of Obagi Nu-Derm ® Sunfader ® contains: ACTIVES: Hydroquinone, USP 4% (40mg/g); Octinoxate, USP 7.5%; Oxybenzone, USP 5.5% INACTIVES: ascorbic acid, BHT, butylparaben, cetyl alcohol, disodium EDTA, glycerin, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tocopheryl acetate, water (aqua)

What Is Hydroquinone, Octisalate And Zinc Oxide Used For?

INDICATIONS AND USAGE For 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 and 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. 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

Side Effects (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 the 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.

Warnings and 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. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Close patient supervision is recommended. WARNINGS: Avoid contact with eyes, nose, mouth and lips. In case of accidental contact, 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. 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 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

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.

Pregnancy and Breastfeeding

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.

How Supplied

HOW SUPPLIED Obagi Nu-Derm ® Clear is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-101-36 Obagi Nu-Derm Blender ® is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-100-36 Net wt. 1 oz. (28 g) bottle NDC 62032-100-10 Obagi Nu-Derm Sunfader ® is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-116-36 Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight. 1-800-636-7546 Figure

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.