Label: IRIS- isopropyl alcohol liquid

  • NDC Code(s): 61504-810-08, 61504-810-43, 61504-810-72
  • Packager: AMERIFOODS TRADING COMPANY
  • 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 December 19, 2022

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  • Active Ingredient

    Isopropyl alcohol 70%

  • Purpose

    first aid antiseptic

  • Uses

    helps prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only. If taken interannly 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 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 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
  • Inactive Ingredient

    water

  • Adverse reactions

    Quality Guaranteed or Your Money Back

    DISTRIBUTED BY: AMERIFOODS TRADING CO.

    P. O. BOX 512377, LOS ANGELES, CA 90051-0377

  • principal display panel

    61504-810-43

    Iris

    70% Isopropyl Alcohol

    First Aid Antiseptic

    For Treatment of Minor Cuts & Abrasions

    Topical Antiseptic

    For Rubbing and Massaging

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

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

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

    NET 16 FL OZ (1PT) 473mL

    image description

  • INGREDIENTS AND APPEARANCE
    IRIS 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61504-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 30 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61504-810-083785 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package10/01/2014
    2NDC:61504-810-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2014
    3NDC:61504-810-72295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2014
    Labeler - AMERIFOODS TRADING COMPANY (626388680)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(61504-810)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(61504-810)
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