Label: ANTIMICROBIAL FOAMING HAND- 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 July 7, 2022

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  • Active Ingredient (in each use)

    Benzalkonium Chloride .13%

  • Purpose

    Antimicrobial

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only

    When using this product

    Avoid contact with eyes. In case of contact flush eyes with water. Do not ingest,

    Stop use and ask a doctor if

    irritation or redness develop or condition persists.

    Keep Out Of Reach Of Children

    If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply to wet hands. Work into a lather and rinse thoroughly.

  • Other Information

    Store between 40ºF and 120ºF

  • Inactive ingredinets

    Water, Cocamidopropyl Betaine,Glycerine, Caprylyl Glucoside, Tetrasodium EDTA, Benzisothiazolinone, Methylisothiazolinone, Fragrance, Citric Acid, Aloe Vera, Yellow #5, Red #40

  • PRINCIPAL DISPLAY PANEL

    Sample

    sample

    16 oz

    16 oz

    1 Gallon

    gallon

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAMING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81775-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    Product Characteristics
    Colororange (Orange Liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81775-100-0150.28 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2022
    2NDC:81775-100-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2022
    3NDC:81775-100-033785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2022
    Labeler - Health Technology Professional Products, Inc (622285547)
    Registrant - Health Technology Professional Products, Inc (622285547)
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