ISOPROPYL ALCOHOL LIQUID [FOODHOLD U.S.A., LLC]

ISOPROPYL ALCOHOL LIQUID [FOODHOLD U.S.A., LLC]
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NDC 41520-804-43, 41520-804-45
Set ID 8a4a6e8b-2306-4079-8d2a-4b1cc0896de1
Category HUMAN OTC DRUG LABEL
Packager FOODHOLD U.S.A., LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Isopropyl alcohol 91%

  • Purpose

    First aid antiseptic

  • Use

    helps prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • 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 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 this product on the 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
    • will product serious gastric disturbances if taken internally
  • Inactive ingredients

    water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY

    FOODHOLD U.S.A., LLC

    LANDOVR, MD 20785

    1-877-846-9949

    Quality Guaranteed or your money back

    804.003/804AA

  • principal display panel

    CAREONE

    91% ISOPROPYL ALCOHOL

    FIRST AID ANTISEPTIC

    Topical antispetic & sanitizer

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

    Use only in a well-ventilate area; fumes can be harmful

    CAUTION: Do not point at self or others; product will squirt when squeezed.

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.91 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-804-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/08/2015
    2NDC:41520-804-45473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/08/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/08/2015
    Labeler - FOODHOLD U.S.A., LLC (809183973)
    Registrant - Vi-Jon Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(41520-804)

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