Label: SOFTENSURE FOAM ANTIMICROBIAL- chloroxylenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2024

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  • ACTIVE INGREDIENT

    Active ingredient

    Chloroxylenol 1.0%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    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

    Warnings

    For external use only

    When using this product

    do not use in or near eyes

    Stop use and ask a doctor ifirritation and redness develop.

    Keep out of reach of children.

    If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands and wrists with clean, running water
    • apply appropriate amount of product
    • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
    • rinse thoroughly with running water
    • dry hands completely (incomplete drying may result in chapped skin)
  • STORAGE AND HANDLING

    Other information

    store in a cool, dry place below 104 oF (40 oC)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

  • QUESTIONS

    Questions?

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

  • PRINCIPAL DISPLAY PANEL

    versaclenz compatible

    SoftenSure

    foam soap

    antimicrobial

    BEST

    SANITIZERS

    INC.

    Net Contents:

    container label

  • INGREDIENTS AND APPEARANCE
    SOFTENSURE FOAM ANTIMICROBIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-127-051250 mL in 1 BOX; Type 0: Not a Combination Product05/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/15/2019
    Labeler - Best Sanitizers, Inc. (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc.627278224manufacture(59900-127)
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