Label: ALOE FORMULA ANTIBACTERIAL- 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 April 27, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    for hand-washing to decrease bacteria on the skin.

  • Warnings

    For external use only

  • When using this product

    ■ do not get into eyes.

    ■ if contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    ■ irritation and redness develops

  • Keep out of reach of children

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

  • Directions

    ■ Squeeze into hands and lather with water. Rinse well

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glyceryl Laurate, Phenoxyethanol, Fragrance, PEG-150 Distearate, Aloe Barbadensis Leaf Juice, Disodium EDTA, Citric Acid, Magnesium Chloride, Methylchloroisothiazolinone, Magnesium Nitrate, Methylisothiazolinone

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    ALOE FORMULA  ANTIBACTERIAL
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76383-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76383-019-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2020
    Labeler - BBC Group Ltd (421270060)
    Establishment
    NameAddressID/FEIBusiness Operations
    BBC Group Ltd421270060manufacture(76383-019)
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