NU-DERM BLENDER Skin Lightener and Blending, NU-DERM CLEAR Skin Bleaching and Corrector, NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE HYDROQUINONE OBAGI COSMECEUTICALS LLC FDA Approved Hydroquinone is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designed 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. Each gram of Obagi Nu-Derm Clear contains: Active ingredient: Hydroquinone USP, 4% (40 mg/g) Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben Each gram of Obagi Nu-Derm Blender contains: Active ingredient: Hydroquinone USP, 4% (40 mg/g) Inactive ingredients: water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT Each gram of Obagi Nu-Derm Sunfader contains: Active ingredients: Hydroquinone USP, 4% (40 mg/g); Octinoxate USP, 7.5%; Oxybenzone USP, 5.5% Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, saponins, propylparaben, butylparaben Chemical Structure

Drug Facts

Composition & Profile

Strengths
57 g 28 g
Treats Conditions
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
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
UPC
0362032100364 0362032116365 0362032101361
UNII
95OOS7VE0Y 4Y5P7MUD51 XV74C1N1AE
Packaging

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°C-25°C (59°F-77°F). Keep out of direct sunlight.; PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 3 OBAGI NU-DERM ® NDC 62032-101-36 AM CLEAR PM 3 SKIN BLEACHING & CORRECTOR CREAM HYDROQUINONE USP, 4% Rx ONLY Net wt. 2 oz. (57g) PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 3; PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 5 OBAGI NU-DERM ® NDC 62032-100-36 BLENDER ® PM 5 SKIN LIGHTENER & BLENDING CREAM HYDROQUINONE USP, 4% Rx ONLY Net wt. 2 oz. (57g) PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 5; PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 6 OBAGI NU-DERM ® NDC 62032-116-36 AM 6 SUNFADER ® HYDROQUINONE USP, 4% SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA-FREE Rx only Net wt. 2 oz. (57 g) PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 6

Package Descriptions
  • 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°C-25°C (59°F-77°F). Keep out of direct sunlight.
  • PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 3 OBAGI NU-DERM ® NDC 62032-101-36 AM CLEAR PM 3 SKIN BLEACHING & CORRECTOR CREAM HYDROQUINONE USP, 4% Rx ONLY Net wt. 2 oz. (57g) PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 3
  • PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 5 OBAGI NU-DERM ® NDC 62032-100-36 BLENDER ® PM 5 SKIN LIGHTENER & BLENDING CREAM HYDROQUINONE USP, 4% Rx ONLY Net wt. 2 oz. (57g) PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 5
  • PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 6 OBAGI NU-DERM ® NDC 62032-116-36 AM 6 SUNFADER ® HYDROQUINONE USP, 4% SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA-FREE Rx only Net wt. 2 oz. (57 g) PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 6

Overview

Hydroquinone is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designed 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. Each gram of Obagi Nu-Derm Clear contains: Active ingredient: Hydroquinone USP, 4% (40 mg/g) Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben Each gram of Obagi Nu-Derm Blender contains: Active ingredient: Hydroquinone USP, 4% (40 mg/g) Inactive ingredients: water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT Each gram of Obagi Nu-Derm Sunfader contains: Active ingredients: Hydroquinone USP, 4% (40 mg/g); Octinoxate USP, 7.5%; Oxybenzone USP, 5.5% Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, saponins, propylparaben, butylparaben Chemical Structure

Indications & Usage

For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

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, a sunblocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

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, product should be discontinued and physician consulted. 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 .
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 the physician notified immediately.

Storage & Handling

Store at controlled room temperature: 15°C-25°C (59°F-77°F). Keep out of direct sunlight.


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