ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [FOUR SEASONS TRADING INC]

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ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [FOUR SEASONS TRADING INC]
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NDC 69274-002-01, 69274-002-02, 69274-002-03, 69274-002-04, 69274-002-05, 69274-002-06, 69274-002-07
Set ID ddce0b1f-3b30-4a38-aced-6765a16831d0
Category HUMAN OTC DRUG LABEL
Packager FOUR SEASONS TRADING INC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredients (by volume)

    Isopropyl alcohol (50% concentrate)

  • PURPOSE

    Purpose

    topical antimicrobial

  • INDICATIONS & USAGE

    Uses

    • to decrease germs in minor cuts and scrapes
    • helps relieve minor muscular aches due to exertion
  • 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.

  • WHEN USING

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area
  • 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 of 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 Ingredients

    Water, Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

    TOPICAL ANTIMICROBIAL

    12 FL.OZ (354 mL)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69274-002
    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:69274-002-01118 mL in 1 BOTTLE, PLASTIC
    2NDC:69274-002-02177 mL in 1 BOTTLE, PLASTIC
    3NDC:69274-002-03237 mL in 1 BOTTLE, PLASTIC
    4NDC:69274-002-04296 mL in 1 BOTTLE, PLASTIC
    5NDC:69274-002-05354 mL in 1 BOTTLE, PLASTIC
    6NDC:69274-002-06414 mL in 1 BOTTLE, PLASTIC
    7NDC:69274-002-07473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/25/2014
    Labeler - FOUR SEASONS TRADING INC (169331464)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(69274-002)
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