Label: SUPER SPOT REMOVER ACNE TREATMENT- salicylic acid gel

  • NDC Code(s): 59427-005-01
  • Packager: ORIGINS NATURAL RESOURCES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 25, 2024

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  • Active ingredient

    Salicylic Acid 1.5%

  • Purpose

    Acne treatment

  • Uses

    • for the management of acne
    • clears acne blemishes
    • helps prevent development of new acne blemishes
  • Warnings

    For external use only.

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

    When using this product

    skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If this occurs, only use one toptical acne medication at the same time. If this occurs, only use one topical acne medication at a time.

  • Directions

    • Cleanse skin thoroughly before applying
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive ingredients

    alcohol denat.,hamamelis virginiana (witch hazel) water,water\aqua\eau,acrylates/c10-30 alkyl acrylate crosspolymer,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,eugenia caryophyllus (clove) bud oil1,origanum heracleoticum flower oil1,eugenol,sodium sulfite,sodium metabisulfite,disodium edta,phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    ORIGINS

    Super Spot
    Remover     ™

    Acne treatment gel

    salicylic acid 1.5%

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

    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
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    WATER (UNII: 059QF0KO0R)  
    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)  
    FU LING (UNII: XH37TWY5O4)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    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 DrugM00604/01/2012
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    BENTLEY LABORATORIES, LLC068351753manufacture(59427-005)
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