Label: ANTIBACTERIAL HAND FREE- benzalkonium chloride gel

  • 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 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active Ingredient(s)

    BENZALKONIUM CHLORIDE: 0.1%

  • Purpose

    Antiseptic

  • Use

    Use: Used for antibacterial cleaning of hand skin

  • Warnings

    Warning: For external use only. Discontinue use if skin irritation occurs. Avoid contact with eyes. Flammable. Keep away from fire source

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions: Apply appropriate amount to plams, rub your hands quickly untill they are dry. Also be sure to clean your finger tips, finger joints and other parts. Don't need to wash

  • Inactive ingredients

    Inactive Ingredients: Alcohol, Water, Carbomer, Sodium Hydroxide

  • STORAGE AND HANDLING

    Storage: Store in cool dry place away from light at room temperature

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND FREE 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74532-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74532-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/04/2020
    Labeler - ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD. (542141447)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHONGSHAN DIOS TRADING COMMERCIAL CO., LTD.542141447manufacture(74532-002)
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