The following Structured Product Label (SPL) was submitted to the FDA by Obagi Cosmeceuticals Llc for the product Nu-derm Sunfader (NDC 62032-116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, pregnancy category c, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Rx Only
For external use only
⍰ 1-800-636-7546
Manufactured for:
Obagi Cosmeceuticals LLC,
Long Beach, CA 90806
All products/brand names, whether designated by notice or not (®/TM), are trademarks of Obagi Cosmeceuticals LLC
©2018 Obagi Cosmeceuticals LLC.
All rights reserved.
www.obagi.com
Revised 03/2018
9458403
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 C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.
Chemical Structure (Nu Derm 01)
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
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 sunblocking agents or sunscreen agents contained in Obagi Nu-Derm Sunfader and Obagi Nu-Derm Sun Shield Matte Broad Spectrum SPF 50.
For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
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.
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.
(Also 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.
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.
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.
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.
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)
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)
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)
* Please review the disclaimer below.
