Label: HANDSOAP- benzalkonium chloride soap

  • NDC Code(s): 51316-705-07, 51316-705-32
  • Packager: CVS Pharmacy Inc.
  • 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 August 5, 2022

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride

  • PURPOSE

    Antibacterial- Helps eliminate bacteria on hands.

  • WARNINGS

    For external use only

    Avoid contact with eyes, If this occurs, rinse throughly with water.

    Stop use and ask a doctor if irritation or redness develops and lasts

    In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.

  • DOSAGE & ADMINISTRATION

    Apply onto dry hands, work into a lather, rinse and dry throughly.

  • STORAGE AND HANDLING

    Store at room temperature

  • INACTIVE INGREDIENT

    Water( Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730).

  • INDICATIONS & USAGE

    Helps eliminate bacteria on the skin

  • PRINCIPAL DISPLAY PANEL

    PDP 132oz

  • INGREDIENTS AND APPEARANCE
    HANDSOAP 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-705
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIRECT BLUE 1 (UNII: 8NN34MAQ6H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-705-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/04/2022
    2NDC:51316-705-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/04/2022
    Labeler - CVS Pharmacy Inc. (062312574)
    Registrant - Apollo Health and Beauty Care Inc (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(51316-705)
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