ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL (ISOPROPYL ALCOHOL) LIQUID [PIONEER ASSOCIATES]

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ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL (ISOPROPYL ALCOHOL) LIQUID [PIONEER ASSOCIATES]
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NDC 53033-002-01, 53033-002-02, 53033-002-03, 53033-002-04, 53033-002-05, 53033-002-06, 53033-002-07
Set ID c5dc1b7e-df29-4d5b-bd9d-5e13266b2dfc
Category HUMAN OTC DRUG LABEL
Packager Pioneer Associates
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active ingredient (by volume)

    Isopropyl alcohol (50% conc.)

  • PURPOSE

    Purpose

    first aid antiseptic

  • INDICATIONS & USAGE

    Uses

    • first aid to help prevent risk of infection in:
    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally
  • ASK DOCTOR

    Ask a doctor before use if you have deep puncture wounds or serious burns

  • DO NOT USE

    When using this product

    • do not get into eyes or mucous membranes
    • use in well-ventilated area: forms may be toxic
  • STOP USE

    Stop use and ask a doctor if condition persists or gets worse

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of an accidental ingestion, contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • apply to skin directly or with clean gauze, cotton or swab
    • for rubbing apply liberally and rub with hands
  • SPL UNCLASSIFIED SECTION

    Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
    • keep bottle tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredient

    Water (Aqua), methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    CAVALIER ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN OIL

    FIRST AID ANTISEPTIC

    12 FL.OZ (354 mL)

  • PRINCIPAL DISPLAY PANEL

    alcohol-wintergreen-50

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53033-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53033-002-01119 mL in 1 BOTTLE, PLASTIC
    2NDC:53033-002-02178 mL in 1 BOTTLE, PLASTIC
    3NDC:53033-002-03237 mL in 1 BOTTLE, PLASTIC
    4NDC:53033-002-04295 mL in 1 BOTTLE, PLASTIC
    5NDC:53033-002-05354 mL in 1 BOTTLE, PLASTIC
    6NDC:53033-002-06414 mL in 1 BOTTLE, PLASTIC
    7NDC:53033-002-07473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A08/24/2012
    Labeler - Pioneer Associates (012604336)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(53033-002)
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