QUITACALLOS (SALICYLIC ACID) CREAM [CARIBE NATURAL, INC]

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QUITACALLOS (SALICYLIC ACID) CREAM [CARIBE NATURAL, INC]
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NDC 59561-712-05
Set ID ec111e88-bd6a-4503-acc4-e0cc26b0d1ce
Category HUMAN OTC DRUG LABEL
Packager Caribe Natural, Inc
Generic Name
Product Class
Product Number
Application Number PART358F
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  • ACTIVE INGREDIENT

    ACTIVE INGREDEINT: Salicylic Acid 17% (w/w)

  • PURPOSE

    Corn & Callus Remover

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • INDICATIONS & USAGE

    QuitaCallos

    Removedor de Callos

    Corn & Callus Remover

    Salicylic Acid 17%

  • DOSAGE & ADMINISTRATION

    Directions: Wash affected area and dry thoroughly. Brush on corn or callus only, not on healthy skin. Let dry. Repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed). You may also soak corn/callus in warm water for 5 minutes to assist in removal.

  • WARNINGS

    Warnings: For external use only. Do not use this product on irritated skin, or on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation. If discomfort persists, see your doctor or a podiatrist. Extremely flammable. Keep away from fire or flame. Cap bottle tightly and store at room temperature away from heat. If product gets into eye, flush with water for 15 minutes. Avoid inhaling vapors.

  • INACTIVE INGREDIENT

    Inactive Ingredients: flexible collodion, isopropyl alcohol.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    QUITACALLOS 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-712
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PYROXYLIN (UNII: KYR8BR2X6O)  
    ETHER (UNII: 0F5N573A2Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59561-712-0515 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F05/05/2015
    Labeler - Caribe Natural, Inc (624210480)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfumes, Inc101312044manufacture(59561-712)
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