The following Structured Product Label (SPL) was submitted to the FDA by Omp, Inc. for the product Nu-derm System Normal-dry (NDC 62032-520). 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 clear (skin bleaching and corrector cream) ndc 62032-101-36 net wt. 2 oz. (57 g) hydroquinone usp, 4% rx only am+pm, indications and usage, dosage and administration, warnings, description, active ingredient, inactive ingredients, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Dark spots may appear on the surface of your skin, but they actually start deep within the skin's layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Specially formulated for blending purposes as part of the Obagi Nu-Derm System.
Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-size amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your 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 sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-size drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care 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 sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
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.
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.
For external use only
Each gram of Obagi Nu-Derm Clear contains:
Each gram of Obagi Nu-Derm Blender contains:
Hydroquinone USP, 4% (40 mg/g)
Hydroquinone USP, 4% (40 mg/g)
water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben
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
1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum
See enclosed Package Insert for full prescribing information.
Rx ONLY. FOR EXTERNAL USE ONLY.
See enclosed Package Insert for full prescribing information.
Rx ONLY. FOR EXTERNAL USE ONLY.
Travel Bag and Patient Instruction Guide
Obagi Hydrate is a trademark, and Blender, Exfoderm, Nu-Derm, and the Obagi logo are registered trademarks, of OMP, Inc.
Refissa is a registered trademark of Spear Pharmaceuticals, Inc.
Distributed by OMP, Inc., Long Beach, CA 90806
©2012 Obagi Medical Products, Inc. All rights reserved.
obagi.com Made in USA 41706111Z 7061
Drug Facts
A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce the signs of aging and correct uneven skin tone. May be used with Tretinoin Cream
Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
or Refissa®Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN.
as prescribed by a physician.Store at controlled room temperature 15°C–25°C (59°F–77°F).
This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.
Octinoxate 7.5%
Zinc Oxide 10.5%
Sunscreen
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.
1.800.636.7546
Monday–Friday 9 a.m.–4 p.m. Pacific Time
NDC# 62032-520-00
OBAGI®
MEDICAL
NU-DERM® SYSTEM
NORMAL DRY
Skin Transformation Kit
Principal Display Panel (Kit Carton)
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