Label: ANTIBACTERIAL FOAMING 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 April 7, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride

  • Purpose

    Antimicrobial

  • Uses

    Sanitizes hands to help reduce bacteria that potentially cause diseases.

  • Warnings

    For External use only. Use on hands only. Do not use over large areas of the body.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop Use and ask a doctor if irritation and redness develops , or persist for more than 72 hours.

    Keep out of reach of children

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

  • Directions

    Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until hands are entirely dry.

  • Other information

    Store at room temperature.

  • Inactive Ingredients

    Leaf Juice, Water, Glycerin, Aloe Barbadensis Bisabolol , PEG-8, Disodium EDTA, Polysorbate-20, PEG-40, Sorbitan Peroleate, Allantoin, Sodium Benzoate, Fragrance

  • Questions?

    (800) 638-8149

  • PRINCIPAL DISPLAY PANEL - 281 ml Bottle Label

    Makéta™

    antimicrobial
    FOAMING HAND
    SANITIZER

    kills 99.99%
    of all germs

    9.5 fl. oz. (281 ml)

    PRINCIPAL DISPLAY PANEL - 281 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72102-056
    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)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    Allantoin (UNII: 344S277G0Z)  
    Aloe vera leaf (UNII: ZY81Z83H0X)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    PEG-8 Stearate (UNII: 2P9L47VI5E)  
    PEG-40 Sorbitan diisostearate (UNII: JL4CCU7I1G)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72102-056-09281 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E04/20/2020
    Labeler - Maketa,LLC (081031516)
    Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc. (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc.078831987MANUFACTURE(72102-056) , LABEL(72102-056) , PACK(72102-056)
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