FDA Label for Nu-derm System Normal-dry Skin Transformation Trial

Other

Gentle Cleanser 2 fl. oz. (59 mL.) AM+PM

A mild facial cleanser that provides gentle yet effective cleansing for normal to dry skin. For skin that's beautifully clean and fresh, the Nu-Derm Gentle Cleanser instantly dissolves excess oil, makeup, and other everyday impurities, without stripping your skin of its natural protective oils, and prepares your skin for the next step in your skin care regimen.

Toner 2 fl. oz. (59 mL.) AM+PM

An essential step in your daily skin care routine, this alcohol-free, non-drying toner helps adjust your skin's pH for increased penetration of product ingredients. Use after cleansing to remove impurities and dead skin cells and to prepare the skin for hydration or appropriate products.

Clear (Skin Bleaching and Corrector Cream) NDC 62032-101-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only AM+PM

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.

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.

Each gram of Obagi Nu-Derm Clear contains:

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Exfoderm^® (Skin Smoothing Lotion) Net wt. 1 oz. (28 g.) AM

A lightweight lotion that exfoliates the top layer of skin, removing dull, old skin cells while promoting new skin cells for a brighter complexion. Specifically developed for normal to dry skin, this gentle, skin-enhancing formula contains a plant acid (phytic acid) to help transform the appearance of damaged skin and reveal your skin's radiance.

Blender^® (Skin Lightener and Blending Cream) NDC 62032-100-36 Net wt. 1 oz. (28 g.) Hydroquinone USP, 4% Rx Only PM

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.

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.

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.

Each gram of Obagi Nu-Derm Blender contains:

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Sun Shield Matte Broad Spectrum SPF 50 Net wt. 1 oz. (28 g.)

This sunscreen combines UVB absorption and UVA protection in an elegant, matte finish that is non-comedogenic, allergy tested, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

Drug Facts

Directions

Use twice daily, morning and evening. Massage a small amount of cleanser and water onto skin. Rinse with lukewarm water and gently pat dry.

Use daily, in the morning and evening after cleansing. Saturate a cotton pad and gently wipe over entire face. Do not rinse.

Use daily, in the morning. Squeeze a small amount (approximately 1-2 pea-sized drops) onto your hands. Using your fingertips, apply evenly to the entire face. Massage until completely absorbed.

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
• 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 value of SPF 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
  
  

Otc - Do Not Use

Avoid getting into eyes. For external use only.

Avoid getting into eyes. For external use only.

Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Avoid getting into eyes. For external use only.

Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

For external use only

Do not use on damaged or broken skin

Ingredients

water (aqua), cocamidopropyl betaine, glycerin, sodium lauroyl oat amino acids, aloe barbadensis leaf juice (aloe barbadensis), sodium laureth sulfate, glycereth-7, prunus armeniaca (apricot) kernel oil, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, oleyl lactate, ethoxydiglycol, triethanolamine, salvia officinalis (sage) leaf extract (salvia officinalis), borago officinalis extract, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), yellow 5 (CI 19140)

water (aqua), hamamelis virginiana (witch hazel) water, aloe barbadensis leaf juice (aloe barbadensis), potassium alum, sodium PCA, panthenol, DMDM hydantoin, polysorbate 80, allantoin, glycerin, salvia officinalis (sage) leaf extract (salvia officinalis), borago officinalis extract, calendula officinalis flower extract (calendula officinalis), saponins, iodopropynyl butylcarbamate, fragrance (parfum), blue 1 (CI 42090)

water (aqua), ethoxydiglycol, glycerin, phytic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, canola oil, isohexadecane, magnesium aluminum silicate, potassium cetyl phosphate, cetyl alcohol, bis-diglyceryl polyacyladipate-2, dimethicone, polysorbate 60, PEG-150 stearate, steareth-20, xanthan gum, glycereth-7, tocopheryl acetate, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben

Indications And Usage

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.

Dosage And Administration

Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-sized 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-sized 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.

Active Ingredient

Hydroquinone USP, 4% (40 mg/g)

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

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 crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

Travel Bag And Patient Instruction Guide

Store at controlled room temperature 15°C–25°C (59°F–77°F).

Blender, Exfoderm, Nu-Derm, Obagi and the Obagi logo
are registered trademarks of OMP, Inc.

Refissa is a registered trademark or Spear Pharmaceuticals, Inc.
Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All Rights Reserved.
OBAGI.COM Made in USA 40706310Z 7063

Otc - Purpose

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - 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.

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 Or Comments?

1.800.636.7546
Monday–Friday 9 a.m.-4 p.m. Pacific Time

Principal Display Panel - Kit Carton

NDC# 62032-516-60

OBAGI^®
MEDICAL

NU-DERM^® SYSTEM

NORMAL DRY

Skin Transformation Trial Kit

PRINCIPAL DISPLAY PANEL - Kit Carton - nu derm 01