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

ISOPROPYL ALCOHOL LIQUID [FOODHOLD U.S.A., LLC]
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NDC 41520-845-43
Set ID 0c8f37da-7112-4e82-a058-2e7433488f36
Category HUMAN OTC DRUG LABEL
Packager Foodhold U.S.A., LLC
Generic Name
Product Class
Product Number
Application Number PART344
  • Active ingredients

    Isopropyl alcohol 70%

  • 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 if

    you have 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 gettting 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

    blue 1, glycerin, methyl salicylate, water, yellow 5

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

    Quality Guaranteed or your money back.

    845.003/845AE

  • package

    CARE ONE

    70% ISOPROPYL ALCOHOL

    FIRST AID ANTISEPTIC

    With wintergreen & glycerin

    For rubbing and massaging

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

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

    CAUTION: Do not point at sel 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:41520-845
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL613 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-845-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34404/07/2015
    Labeler - Foodhold U.S.A., LLC (809183973)
    Registrant - Vi-Jon Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(41520-845)

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