Label: AC OUT SPOT STOP SERUM- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 25, 2012

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  • ACTIVE INGREDIENT

    salicylic acid
  • INACTIVE INGREDIENT

    water, alcohol, butylene glycol, chrysanthemum morifolium flower extract, magnolia kobus bark extract, camella sinensis leaf extract, ghujopsis dolabrata branch extract, citrus grandis fruit extract, cnidium officinale root extract, acorus calamus root extract, artemisia princeps leaf extract, sophora angustifolia root extract, prunus mume fruit extract, licorice root extract, chamaecyparis obtusa water, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, fragrance
  • PURPOSE

    skin proctectant
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    1.  On clean face, only apply on troubled areas. Do not rub.

     2.  When applying on top of a make up, use tip of the tube

          to apply and soothe troubled areas quickly
  • WARNINGS

    When using this product
    - keep out of eyes, ears, and mouth.  If contact occurs, rinse with plenty of cold water right away and contact a physician.  If swallowing, drink plenty of water and contact a physician
  • DOSAGE & ADMINISTRATION

    for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    AC OUT SPOT STOP SERUM 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-1201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
    MAGNOLIA KOBUS BARK (UNII: 54LVP49595)  
    THUJOPSIS DOLABRATA LEAFY TWIG (UNII: P24JH909CP)  
    PUMMELO (UNII: ET1TN5W71X)  
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    PRUNUS MUME FRUIT (UNII: 639190I8CU)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43948-1201-115 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/27/2012
    Labeler - The Doctors Cosmetics Co., Ltd (687479378)
    Registrant - The Doctors Cosmetics Co., Ltd (687479378)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Doctors Cosmetics Co., Ltd687479378manufacture(43948-1201)
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