Label: BENEMAX ADVANCED HAND SANITIZER- 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 March 11, 2021

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  • Active ingredient

    Isopropyl alcohol 70%, USP

  • Purpose

    Antiseptic

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use
    •     on children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In
    case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may
    be signs of a serious condition.

  • Directions

    • Place enough product on hands or affected area to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Uses

    Antiseptic and Hand Sanitizer to help reduce bacteria that may cause disease. For use when soap & water are unavailable.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Inactive ingredient

    Water

  • Other information

    Store between 15 °C and 30 °C. Avoid freezing and excessive heat above 400 °C (104 °F)

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    BENEMAX ADVANCED HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73700-004
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73700-004-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/25/2021
    Labeler - Nugale Pharmaceutical Inc (202595872)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nugale Pharmaceutical Inc202595872manufacture(73700-004)
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