Label: CLEANSE-AF HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 74966-002-32
  • Packager: California Prison Industry Authority
  • Category: HUMAN OTC DRUG LABEL

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 June 10, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.1%

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizing to help reduce bacteria on skin.

  • Warnings

    For external use only.

  • Ask a doctor before use if you have

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • When using this product

    • Avoid contact with eyes
    • In case of contact, flush eyes with water
    • Do not ingest
  • STOP USE

    Stop use and ask a doctor if redness or irritation develops and persists. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children should be supervised when using this product. If swallowed call a Poison Control Center or get medical help right away.

  • Directions

    • Pump a small amount of foam into palm of hands. Rub thoroughly over all surfaces of both hands. Rub hands briskly unil dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, lautrimonium chloride, water

  • Package Label - Principal Display Panel

    32 FL OZ (946 mL)

    NDC 74966-002-32

    002

  • INGREDIENTS AND APPEARANCE
    CLEANSE-AF HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74966-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74966-002-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2020
    Labeler - California Prison Industry Authority (843406104)
    Establishment
    NameAddressID/FEIBusiness Operations
    California Prison Industry Authority843406104manufacture(74966-002)
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