Label: SOFTENSURE ANTIMICROBIAL LIQUID- chloroxylenol liquid

  • NDC Code(s): 59900-217-01, 59900-217-02, 59900-217-03, 59900-217-04
  • 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

    Chloroxylenol 0.75%

  • 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 amounts 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

    Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No. 8, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    liquid

    soap

    Soften

    Sure

    ANTIMICROBIAL

    LIQUID SOAP

    • Chloroxylenol (PCMX)

    • Light Fragrance

    • For Frequent Use

    Net Contents: 16.9 FL OZ (500mL)

    container label

  • INGREDIENTS AND APPEARANCE
    SOFTENSURE ANTIMICROBIAL LIQUID 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.75 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDE MEA (UNII: C80684146D)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    COCONUT ACID (UNII: 40U37V505D)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    2-AMINOETHANOL (UNII: 5KV86114PT)  
    HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    TETRASODIUM EDTA (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-217-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/26/2023
    2NDC:59900-217-0212 in 1 CASE12/26/2023
    2500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59900-217-031200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/26/2023
    4NDC:59900-217-044 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(59900-217)
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