Label: SOFTENSURE ANTIMICROBIAL FOAM- benzalkonium chloride liquid

  • NDC Code(s): 59900-216-01, 59900-216-02, 59900-216-03, 59900-216-04
  • Packager: Best Sanitizers, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active ingredient

    Benzalkonium Chloride 0.12%

  • Purpose

    Antiseptic Hand Cleanser

  • Uses

    • handwash to help reduce bacteria that potentially can cause disease

    • helps to prevent cross-contamination by hand contact

    • helps to prevent drying of the skin

    • recommended for repeated use

  • Warnings

    For external use only

    When using this product do not use in or near eyes.

    Stop use and ask a doctor if irritation or redness develop.

    Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center immediately.

  • Directions

    • wet hands and wrists with potable water

    • apply appropriate amount of product

    • lather and scrub hands, fingers, fingernails, cuticles, and wrists for at least 20 seconds

    • rinse thoroughly with potable water before handling food

    • dry hands completely (incomplete drying may result in chapped skin)

  • Other information

    store in a cool, dry place below 104° F (40° C)

  • Inactive ingredients

    Water, cocamidopropyl betaine, glycerine, polyethylene-polypropylene glycol, benzyl alcohol, phenoxyethanol, tetrasodium EDTA, dehydroacetic acid, sodium hydroxide, citric acid

  • Questions?

    Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am-4 pm PST

  • PRINCIPAL DISPLAY PANEL

    foam

    soap

    Soften

    Sure

    ANTIMICROBIAL

    FOAM SOAP

    Benzalkonium Chloride •

    Fragrance and Dye Free •

    For Professional Use •

    NSF

    Nonfood Compounds

    Program Listed (E2)

    Registration #166522

    KC

    PAREVE

    Net Contents: 500mL (16.9 FL OZ)

    container label

  • INGREDIENTS AND APPEARANCE
    SOFTENSURE ANTIMICROBIAL FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    TETRASODIUM EDTA (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-216-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/26/2023
    2NDC:59900-216-0212 in 1 CASE12/26/2023
    2500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59900-216-031200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/26/2023
    4NDC:59900-216-044 in 1 CASE12/26/2023
    41200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/26/2023
    Labeler - Best Sanitizers, Inc (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture(59900-216)
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