NDC | 62032-100-10, 62032-101-36, 62032-104-10, 62032-516-60 |
Set ID | 376dd650-fa5f-42a7-b974-6f538a28f7f2 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Obagi Cosmeceuticals LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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SPL UNCLASSIFIED SECTION
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.
- 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 (salvia officinalis), borago officinalis extract, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), yellow 5 (CI 19140)
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SPL UNCLASSIFIED SECTION
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.
- Directions
- Warnings
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Ingredients
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)
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SPL UNCLASSIFIED SECTION
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.
- Indications and usage
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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.
- Warnings
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SPL UNCLASSIFIED SECTION
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:
- Active ingredient
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
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.
- Directions
- Warnings
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Ingredients
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
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SPL UNCLASSIFIED SECTION
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 Cream1 or Refissa2 as prescribed by a physician.
- 1
- Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
- 2
- 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.
- Indications and usage
-
Dosage and administration
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.
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Warnings
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.
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
- SPL UNCLASSIFIED SECTION
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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 - SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
- 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 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
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Inactive ingredients
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
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION TRIAL
hydroquinone, octinoxate, and zinc oxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-516 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-516-60 1 in 1 CARTON 11/07/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 28 g Part 2 1 BOTTLE, PLASTIC 57 g Part 3 1 TUBE 28 g Part 4 1 BOTTLE, PLASTIC 59 mL Part 5 1 BOTTLE, PLASTIC 59 mL Part 6 1 BOTTLE, PLASTIC 28 g Part 1 of 6 NU-DERM BLENDER SKIN LIGHTENER AND BLENDING
hydroquinone creamProduct Information 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 EDETATE DISODIUM (UNII: 7FLD91C86K) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) TROLAMINE SALICYLATE (UNII: H8O4040BHD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 BOTTLE, PLASTIC; 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 2 of 6 NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR
hydroquinone creamProduct Information 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 EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLPARABEN (UNII: 3QPI1U3FV8) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) 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 57 g in 1 BOTTLE, PLASTIC; 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 SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
octinoxate and zinc oxide 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 CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-40 STEARATE (UNII: ECU18C66Q7) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TROPOLONE (UNII: 7L6DL16P1T) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) UBIDECARENONE (UNII: EJ27X76M46) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains 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 11/07/2012 Part 4 of 6 NU-DERM GENTLE CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR GLYCERETH-7 (UNII: 3D2Y91QZ2H) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR SAGE (UNII: 065C5D077J) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR APRICOT KERNEL OIL (UNII: 54JB35T06A) INGR OLEYL LACTATE (UNII: B3AWW0N3GM) INGR CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/1988 Part 5 of 6 NU-DERM TONER
face and neck (excluding shaving preparations) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR POTASSIUM ALUM (UNII: 1L24V9R23S) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR SAGE (UNII: 065C5D077J) INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) INGR POLYSORBATE 80 (UNII: 6OZP39ZG8H) INGR ALLANTOIN (UNII: 344S277G0Z) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) INGR HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/1988 Part 6 of 6 NU-DERM EXFODERM
face and neck (excluding shaving preparations) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR CANOLA OIL (UNII: 331KBJ17RK) INGR ISOHEXADECANE (UNII: 918X1OUF1E) INGR MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR FYTIC ACID (UNII: 7IGF0S7R8I) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR PEG-150 STEARATE (UNII: 7BSG7DF10Q) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR GLYCERETH-7 (UNII: 3D2Y91QZ2H) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/1988 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/07/2012 Labeler - Obagi Cosmeceuticals LLC (790553353) Establishment Name Address ID/FEI Business Operations MILBAR LABORATORIES 195556790 MANUFACTURE(62032-516) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-516) , LABEL(62032-516) , PACK(62032-516) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(62032-516) Establishment Name Address ID/FEI Business Operations Bay Cities Container Corporation 066229618 RELABEL(62032-516) , REPACK(62032-516)