SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]

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SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]
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NDC 59427-005-01
Set ID a0aece76-008b-4af3-be39-13156acc73af
Category HUMAN OTC DRUG LABEL
Packager ORIGINS NATURAL RESOURCES INC.
Generic Name
Product Class
Product Number
Application Number PART333D
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1.50%

  • Purpose

    Acne treatment

  • Uses

    • For the treatment of acne
  • Warnings

    For external use only.

    Avoid eye area.

    Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Keep out of reach of children. If swallowed, call a doctor or contact a Poison Control Center right away.

  • Directions

    • Cleanse skin.
    • Apply a thin layer 1 to 3 times daily or as needed.
    • If dryness or peeling occurs, reduce application to every other day.
  • Inactive ingredients

    water\aqua\eau • alcohol denat. • acrylates/c10-30 alkyl acrylate crosspolymer • hamamelis virginiana (witch hazel) • eugenia caryophyllus (clove) bud oil1, origanum heracleoticum flower oil1, eugenol, limonene • cucumis sativus (cucumber) fruit extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • algae extract • poria cocos sclerotium extract • laminaria saccharina extract • lactobacillus ferment • glycerin • caffeine • butylene glycol • tocopheryl acetate • magnesium ascorbyl phosphate • sodium hydroxide • phenoxyethanol <iln37864>

    1
    essential oil
  • 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 ACID15 mg  in 1 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 CARTON11/24/2020
    110 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D04/01/2012
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277MANUFACTURE(59427-005) , REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(59427-005) , REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326MANUFACTURE(59427-005) , REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(59427-005) , REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774REPACK(59427-005) , RELABEL(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062RELABEL(59427-005) , REPACK(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC PALC102631997REPACK(59427-005) , RELABEL(59427-005)
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