Label: BENEMAX- isopropyl alcohol 70% 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 November 29, 2021

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  • Active ingredient

    Isopropyl alcohol 70%, USP

  • Purpose

    Antimicrobial

  • Uses

    as a hand sanitizer when there is no water, to reduce bacteria on the skin which can cause illness. Recommended for repeated use.

  • Warnings

    Flammable, keep away from fire or flame

    For external use only

    When using this product

    • do not use in or near the eyes
    • in case of contact, rinse eyes thoroughly with water

    Stop use and cantact your doctor

    if a rash on irritation appear and remain at the site of contact

    Keep out of reach of children.

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

  • Directions

    • spray 3·5 pumps of hand sanitizer onto hands or enough to thoroughly cover hands.
    • children under 6 years of age must be supervised when using this product.
  • Other information

    • do not store above 110 0F (43 0C). May discolor certain fabrics or substances
  • Inactive ingredient

    aloe juice (aloe barbadensis), carbomer 940NF, di-alpha-tocopheryl acetate, triethanolamine, glycerin

  • Product Labels

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BENEMAX 
    isopropyl alcohol 70% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73700-001
    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
    ALOE (UNII: V5VD430YW9)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73700-001-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/19/2020
    2NDC:73700-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
    3NDC:73700-001-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
    4NDC:73700-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/19/2020
    Labeler - Nugale Pharmaceutical Inc (202595872)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nugale Pharmaceutical Inc202595872manufacture(73700-001)
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