Label: 50% RUBBING- 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 6, 2022

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  • Active ingredient

    Isopropyl alcohol 50%

  • Purpose

    First aid antiseptic

  • Use

    first aid to help prevent the risk of infection in:

    • minor cuts
    • scarapes
    • burns
  • Warnings

    For external use only. If taken internally serious gastric disturbances will result.

  • Flammable

    • Keep away from fire or flame, heat, spark, electrical
  • Ask a doctor before use

    for deep or puncture wounds, animal bites or serious burns

  • When using this product

    • do not get into eyes
    • do not inhale
    • do not apply over large areas of the body
    • do not use longer than 1 week
  • Stop use and ask a doctor if

    condition persists or gets worse

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Caution

    Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

  • Directions

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

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive ingredient

    water

  • SPL UNCLASSIFIED SECTION

    Distributed by: Perrigo Direct, Inc.

    Peachtree City, Ga 30269

    www.PerrigoDirect.com

    1-888-593-0593

    Pat. D675, 101

  • principal display panel

    NDC 50804-864-43

    GOODSENSE

    50%

    Isopopyl

    Alcohol

    • First Aid Antiseptic
    • For Rubbing and Massaging

    WARNING FLAMMABLE - Keep away from hear, spark, electrical, fire or flame

    Use only in well-ventilated area;

    fumes can be harmful

    CAUTION: Do not point at self or

    others; product will squirt when sqeezed.

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    50% RUBBING 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-864
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-864-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/21/2010
    Labeler - Perrigo Direct, Inc. (076059836)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(50804-864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(50804-864)
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