OBAGI MEDICAL - NU-DERM SYSTEM - NORMAL TO DRY - SKIN TRANSFORMATION TRIAL KIT (OCTINOXATE, ZINC OXIDE) KIT [OMP, INC.]

OBAGI MEDICAL - NU-DERM SYSTEM - NORMAL TO DRY - SKIN TRANSFORMATION TRIAL KIT (OCTINOXATE, ZINC OXIDE) KIT [OMP, INC.]
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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
  • 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

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

  • Warnings

    Avoid getting into eyes. For external use only. Keep out of reach of children.

  • 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

    An essential step in your daily skin care routine, this alcohol-free, nondrying toner helps adjust your skin’s pH. Use after cleansing to remove impurities and dead skin cells and to prepare the skin for hydration or appropriate products.

  • Directions

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

  • Warnings

    Avoid getting into eyes. For external use only. Keep out of reach of children.

  • 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)

  • 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

    The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • 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.

  • 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

    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

    See enclosed Package Insert for prescribing information.

    Rx ONLY. FOR EXTERNAL USE ONLY.

  • 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

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

  • Warnings

    Avoid getting into eyes. For external use only. Keep out of reach of children.

  • 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

  • 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

    The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • 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.

  • 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

    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

    See enclosed Package Insert for prescribing information.

    Rx ONLY. FOR EXTERNAL USE ONLY

  • Sun Shield Broad Spectrum SPF 50 Matte

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%

    Zinc Oxide 10.5%

  • Purpose

    Sunscreen

  • 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

    For external use only

    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.

  • 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
    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

    store at controlled room temperature: 15°C–25°C (59°F–77°F)
    protect this product from excessive heat and direct sun
  • 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?

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

  • Principal Display Panel - Kit Carton

    OBAGI®

    MEDICAL

    OBAGI NU-DERM® SYSTEM

    NORMAL DRY

    Skin Transformation Trial Kit

    Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Trial Kit
  • INGREDIENTS AND APPEARANCE
    OBAGI MEDICAL - NU-DERM SYSTEM - NORMAL TO DRY - SKIN TRANSFORMATION TRIAL KIT 
    octinoxate, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-528
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-528-071 in 1 CARTON; Type 0: Not a Combination Product11/16/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 28 g
    Part 21 TUBE 57 g
    Part 31 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 lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart352
    Part 2 of 6
    NU-DERM CLEAR  SKIN BLEACHING AND CORRECTOR
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:62032-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-101-3657 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/1988
    Part 3 of 6
    NU-DERM BLENDER  SKIN LIGHTENER AND BLENDING
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:62032-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-100-1028 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/1988
    Part 4 of 6
    OBAGI NU-DERM  GENTLE CLEANSER
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGROLEYL LACTATE (UNII: B3AWW0N3GM)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRBORAGE (UNII: PB618V0K2W)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 5 of 6
    OBAGI NU-DERM  TONER
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRBORAGE (UNII: PB618V0K2W)  
    INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 6 of 6
    OBAGI NU-DERM  EXFODERM
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRFYTIC ACID (UNII: 7IGF0S7R8I)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRCANOLA OIL (UNII: 331KBJ17RK)  
    INGRISOHEXADECANE (UNII: 918X1OUF1E)  
    INGRPOTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPEG-150 STEARATE (UNII: 7BSG7DF10Q)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other11/16/2015
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei INC.105803274MANUFACTURE(62032-528, 62032-100, 62032-101) , LABEL(62032-528) , PACK(62032-528) , ANALYSIS(62032-528)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-528)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bay Cities Container Corporation066229618RELABEL(62032-528) , REPACK(62032-528)