NDC | 62032-100-10, 62032-101-36, 62032-528-07 |
Set ID | 2b445250-ab56-4ed1-9ea3-186817d47090 |
Category | HUMAN OTC DRUG LABEL |
Packager | OMP, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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Gentle Cleanser 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 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.
- Directions
- Warnings
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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, borago officinalis extract, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), yellow 5 (CI 19140)
- Toner AM+PM
- Directions
- Warnings
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Ingredients
water (aqua), hamamelis virginiana (witch hazel) water, aloe barbadensis leaf juice, potassium alum, sodium PCA, panthenol, DMDM hydantoin, polysorbate 80, allantoin, glycerin, salvia officinalis (sage) leaf extract, borago officinalis extract, calendula officinalis flower extract, saponins, iodopropynyl butylcarbamate, fragrance (parfum), blue 1 (CI 42090)
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Clear (Skin Bleaching and Corrector Cream) 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.
- Indications and Usage
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Dosage and Administration
Use daily, in the morning and evening. Squeeze a small amount (approximately1-2 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 or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
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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.
Each gram of Obagi Nu-Derm Blender contains:
- Active Ingredient
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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
See enclosed Package Insert for prescribing information.
Rx ONLY. FOR EXTERNAL USE ONLY.
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Exfoderm® (Skin Smoothing Lotion) AM
A lightweight lotion that exfoliates the top layer of skin, removing dull, old skin cells while revealing 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.
- Directions
- Warnings
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Ingredients
water, ethoxydiglycol, glycerin, phytic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, magnesium aluminum silicate, canola oil, isohexadecane, potassium cetyl phosphate, cetyl alcohol, bis-diglyceryl polyacyladipate-2, dimethicone, sodium hydroxide, xanthan gum, phenoxyethanol, glycereth-7, polysorbate 60, methylparaben, PEG-150 stearate, steareth-20, tocopheryl acetate, saponins, ethylparaben, butylparaben, isobutylparaben, propylparaben
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Blender® (Skin Lightener and Blending Cream) 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 signs of aging by correcting uneven skin tone.
- Indications and Usage
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Dosage and Administration
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 or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
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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.
Each gram of Obagi Nu-Derm Blender contains:
- Active Ingredient
-
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
See enclosed Package Insert for prescribing information.
Rx ONLY. FOR EXTERNAL USE ONLY
- Sun Shield Broad Spectrum SPF 50 Matte
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- •
- 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
- •
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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
- Other information
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Inactive ingredients
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
- Questions or comments?
- Principal Display Panel - Kit Carton
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INGREDIENTS AND APPEARANCE
OBAGI MEDICAL - NU-DERM SYSTEM - NORMAL TO DRY - SKIN TRANSFORMATION TRIAL KIT
octinoxate, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-528 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-528-07 1 in 1 CARTON; Type 0: Not a Combination Product 11/16/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 28 g Part 2 1 TUBE 57 g Part 3 1 TUBE 28 g Part 4 59 Part 5 59 Part 6 28 Part 1 of 6 OBAGI NU-DERM SUN SHIELD MATTE BROAD SPECTRUM SPF 50
sunscreen lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 105 mg in 1 g Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORPHENESIN (UNII: I670DAL4SZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PEG-40 STEARATE (UNII: ECU18C66Q7) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) SQUALANE (UNII: GW89575KF9) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TROPOLONE (UNII: 7L6DL16P1T) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 Part 2 of 6 NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR
hydroquinone creamProduct Information Item Code (Source) NDC:62032-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) LACTIC ACID (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-101-36 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/1988 Part 3 of 6 NU-DERM BLENDER SKIN LIGHTENER AND BLENDING
hydroquinone creamProduct Information Item Code (Source) NDC:62032-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TROLAMINE SALICYLATE (UNII: H8O4040BHD) LACTIC ACID (UNII: 33X04XA5AT) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM METABISULFITE (UNII: 4VON5FNS3C) ASCORBIC ACID (UNII: PQ6CK8PD0R) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-100-10 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/1988 Part 4 of 6 OBAGI NU-DERM GENTLE CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR GLYCERETH-7 (UNII: 3D2Y91QZ2H) INGR APRICOT KERNEL OIL (UNII: 54JB35T06A) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR OLEYL LACTATE (UNII: B3AWW0N3GM) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR SAGE (UNII: 065C5D077J) INGR BORAGE (UNII: PB618V0K2W) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 5 of 6 OBAGI NU-DERM TONER
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR POTASSIUM ALUM (UNII: 1L24V9R23S) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR POLYSORBATE 80 (UNII: 6OZP39ZG8H) INGR ALLANTOIN (UNII: 344S277G0Z) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SAGE (UNII: 065C5D077J) INGR BORAGE (UNII: PB618V0K2W) INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 6 of 6 OBAGI NU-DERM EXFODERM
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR FYTIC ACID (UNII: 7IGF0S7R8I) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) INGR CANOLA OIL (UNII: 331KBJ17RK) INGR ISOHEXADECANE (UNII: 918X1OUF1E) INGR POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR GLYCERETH-7 (UNII: 3D2Y91QZ2H) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PEG-150 STEARATE (UNII: 7BSG7DF10Q) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/16/2015 Labeler - OMP, Inc. (790553353) Establishment Name Address ID/FEI Business Operations Ei INC. 105803274 MANUFACTURE(62032-528, 62032-100, 62032-101) , LABEL(62032-528) , PACK(62032-528) , ANALYSIS(62032-528) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(62032-528) Establishment Name Address ID/FEI Business Operations Bay Cities Container Corporation 066229618 RELABEL(62032-528) , REPACK(62032-528)