ISOPROPYL RUBBING ALCOHOL 50 PERCENT WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [FREDS INC]

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ISOPROPYL RUBBING ALCOHOL 50 PERCENT WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [FREDS INC]
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NDC 55315-272-16
Set ID 1b69714e-acc5-44b3-990f-c5561ab2eb17
Category HUMAN OTC DRUG LABEL
Packager Freds Inc
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient (by volume)

    Isopropyl alcohol (50% conc.)

  • Purpose

    first aid antiseptic

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • Warnings

    For external use only.

    • flammable, keep away from fire or flame
    • if taken internally serious gastric disturbances will result

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than one week unless directed by a doctor
    • do not use otherwise than as directed

    Stop use and ask a doctor if

    • condition persists or gets worse

    Keep out of reach of children.

    In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • clean affected area
    • apply small amount of this product on the area 1-3 times daily
    • if bandaged, let dry first
    • may be covered with a sterile bandage
  • Other information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive ingredients

    FD&C green #3, FD&C yellow #5, methyl salicylate, purified water

  • Principal Display Panel

    Wintergreen

    Rubbing Alcohol

    WITH METHYL SALICYLATE

    50% Isopropyl

    First Aid Antiseptic

    DISTRIBUTED BY: fred's, Inc.

    4300 NEW GETWELL RD,

    MEMPHIS, TN 38118

    www.fredsinc.com

    Questions or comments?

    1-855-331-FRED (3733)

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY FOIL UNDER THE CAP IS BROKEN OR MISSING.

  • Package Label

    Isopropyl Alcohol (50% conc.)

    FRED'S PHARMACY Wintergreen Rubbing Alcohol

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL  50 PERCENT WINTERGREEN
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-272
    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)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-272-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/31/2014
    Labeler - Freds Inc (005866116)
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