Label: 50 PERCENT ISOPROPYL ALCOHOL- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 4, 2023

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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.

    • If taken internally, serious gastic disturbances will result

    Flammable, keep away from fire or flame.

    • use only in a well-ventilated area; fumes may be toxic

    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

    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 right away (1-800-222-1222).

  • 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

    purified water

  • Principal Display Panel

    Rubbing Alcohol

    50 % ISOPROPYL

    + FIRST AID + 

    • TOPICAL FIRST AID ANTISEPTIC
    • FOR RUBBING & MASSAGING

    WARNING: FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    FL OZ (mL)

    Questions, Comments?

    customer,questions@wholefoods.com (512) 542-0878

    DISTRIBUTED BY:

    WHOLE FOODS MARKET

    550 BOWIE STREET, AUSTIN, TX 78703

    ©2017 WHOLE FOODS MARKET IP, LP

    www.wholefoodsmarket.com

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

  • Package Label

    Isopropyl Alcohol (50% conc.)

    WHOLE FOOD 365 50% Rubbing Alcohol

  • INGREDIENTS AND APPEARANCE
    50 PERCENT ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-6573
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-6573-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/201712/31/2024
    Labeler - Whole Foods Market (196175616)
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