SUPER SPOT REMOVER ACNE TREATMENT- salicylic acid gel

SUPER SPOT REMOVER ACNE TREATMENT by

Drug Labeling and Warnings

SUPER SPOT REMOVER ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., WHITMAN LABORATORIES, LTD., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER N.V, LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION

    © Origins Nat. Res., Dist.
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 10 ml Carton

    ORIGINS

    Super Spot
    Remover

    Acne treatment gel
    salicylic acid

    .3 fl. oz./oz. liq./
    10 ml e

    Principal Display Panel - 10 ml Carton
  • INGREDIENTS AND APPEARANCE
    SUPER SPOT REMOVER ACNE TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59427-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    witch hazel (UNII: 101I4J0U34)  
    clove oil (UNII: 578389D6D0)  
    eugenol (UNII: 3T8H1794QW)  
    cucumber (UNII: YY7C30VXJT)  
    apple (UNII: B423VGH5S9)  
    scutellaria baicalensis root (UNII: 7J95K7ID2S)  
    saccharina latissima (UNII: 68CMP2MB55)  
    glycerin (UNII: PDC6A3C0OX)  
    caffeine (UNII: 3G6A5W338E)  
    butylene glycol (UNII: 3XUS85K0RA)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    sodium hydroxide (UNII: 55X04QC32I)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 59427-005-011 in 1 CARTON
    110 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D04/01/2012
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(59427-005) , REPACK(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(59427-005) , RELABEL(59427-005)

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