Label: BELLI MOISTURIZING HAND SANITIZER 0.1 PERCENT- benzalkonium chloride lotion

  • 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 January 6, 2022

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.1%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • REDUCES BACTERIA ON THE SKIN

  • WARNINGS

    WHEN USING THIS PRODUCT

    • KEEP OUT OF EYES / RINSE WITH WATER TO REMOVE

    STOP USE AND ASK A DOCTOR IF

    • RASH OR SKIN ORRITATION DEVELOPS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IN CASE OF ACCIDENTAL INGESTION, CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    • PLACE ENOUGH PRODUCT IN YOUR HANDS TO THOROUGHLY COVER YOUR HANDS AND RUB IN.

  • INACTIVE INGREDIENTS

    WATER, SD ALCOHOL 40-B, POLYSORBATE 20, PEG-7 GLYCERYL COCOATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE, CITRUS LIMON (LEMON) PEEL OIL

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hand Sanitizer 2oz

  • INGREDIENTS AND APPEARANCE
    BELLI MOISTURIZING HAND SANITIZER   0.1 PERCENT
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42281-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42281-101-1159 mL in 1 TUBE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - ABT Belli-Materna Inc (947134677)
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