Label: HAND SANITIZER- benzalkonium chloride 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 11, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Warnings

    • For external use only.
    • ­­­­Keep out of eyes. In case of contact, flush eyes water.
    • Stop use and consult a doctor if irritation or redness develops.
  • Uses

    • To decrease bacteria on the skin.

  • Directions

    •Rub thoroughly over all surfaces of both hands.
    •Rub hands together briskly until dry.

  • Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Inactive ingredients:

    water, Cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, propylene glycol, diazolidinyl urea, methyl paraben, propylparaben, citric acid, dihydroxypropyl, PEG-5 linoleammonium.

  • Product Label

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71120-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71120-112-0118 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    2NDC:71120-112-0450 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    3NDC:71120-112-051000 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    4NDC:71120-112-06550 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    5NDC:71120-112-07250 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    6NDC:71120-112-08300 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    7NDC:71120-112-093785 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    8NDC:71120-112-10118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2020
    9NDC:71120-112-11236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2020
    10NDC:71120-112-0224 in 1 PACKAGE10/06/2020
    1018 mL in 1 CONTAINER; Type 0: Not a Combination Product
    11NDC:71120-112-0348 in 1 PACKAGE10/06/2020
    1118 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2020
    Labeler - Sanit Technologies LLC (075711022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Durisan085479946manufacture(71120-112)
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