Label: INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER- benzalkonium chloride soap

  • 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 March 14, 2022

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  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Uses

    Hand sanitizer to reduce microorganisms on the skin.

    Use this product when soap and water are not available.

  • Warnings

    For external use only. FLAMMABLE. This product contains ethyl alcohol.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

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

  • Directions

    Read entire label before using this product.

    Place a palmful (5 grams) of product in one hand.

    Spread on both handsand rub into the skin until dry (1-2 min).

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, D&C Green #5, Fragrance, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, Perfluorohexylethyl Alcohol, Propylene Glycol, Water

  • Purpose

    Antiseptic

  • Keep out of reach of children

    Keep out of the reach of children

  • Label

    Foaming Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79258-795
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M) (DEHYDRATED ALCOHOL - UNII:3K9958V90M) DEHYDRATED ALCOHOL0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79258-795-291000 mL in 1 BAG; Type 0: Not a Combination Product03/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/02/2022
    Labeler - Brady Industries Inc. (034932657)
    Registrant - Betco Corporation (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation005050158manufacture(79258-795) , label(79258-795) , analysis(79258-795) , pack(79258-795)
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