Label: DIVAPROTECT 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 May 1, 2020

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  • Active ingredient

    Benzalkonium Chloride   0.10%

  • PURPOSE

  • Uses

    Effective in destroying harmful bacteria, while moisturizing hands.

  • Warnings

    • 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 ask a doctor if irritation or rash appears and lasts.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

    Aqua/Water, Glyceryl Stearate (and) PEG-100 Stearate, Olea Europaea (Olive) Fruit Oil, Caprylic/Capric Triglycerides, Glycerin, Cetyl alcohol, Olea Europaea (Olive) Oil, Sodium Polyacrylate (and) C13-14 Isoparaffin (and) Laureth-7, Allantoin, Disodium EDTA, Dimethicone, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Butylated Hydrxytoluene, Lavandula Angustifolia, Matricaria Recutita (Chamomile) Extract, Silk Amino Acids, Panthenol

  • Package Label - Principal Display Panel

    Label 1Label 2

    Label 3

  • INGREDIENTS AND APPEARANCE
    DIVAPROTECT HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77116-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BENTONITE (UNII: A3N5ZCN45C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77116-001-01177 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Diva International Inc. (207651758)
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