Label: HAND ANTIBACTERIAL ALCOHOL FREE WITH ALOE VERA- 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 23, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    ■ For Handwashing to help reduce bacteria on the skin.

  • Warnings

    For external use only.

  • When using this product

    ■ keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

  • Stop use and ask a doctor if

    irritation and redness develops and persists.

  • Keep out of reach of children

    If swallowed, contact a doctor or Poison Control Center right away.

  • Directions

    ■ Wet hands. Apply a palmful to hands. ■ Scrub thoroughly for at least 30 seconds and then rinse. ■ Supervise children under 6 years of age when using this product to avoid swallowing

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glyceryl Laurate, Phenoxyethanol, Fragrance, PEG-150 Distearate, Aloe Vera (Aloe Barbadensis) Leaf Extract, Disodium EDTA, Citric Acid, Magnesium Chloride, Methylchloroisothiazoline, Magnesium Nitrate, Methylisothiazolinone

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND ANTIBACTERIAL  ALCOHOL FREE WITH ALOE VERA
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76383-028
    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
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76383-028-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/28/2020
    Labeler - BBC GROUP LIMITED (421270060)
    Establishment
    NameAddressID/FEIBusiness Operations
    BBC GROUP LIMITED421270060manufacture(76383-028)
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