Label: SOFTENSURE FOAM ANTIMICROBIAL- chloroxylenol liquid

  • 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 May 15, 2019

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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 if irritation 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 104o F (40o C)

  • 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 not finalpart333A05/15/2019
    Labeler - Best Sanitizers, Inc. (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc.627278224manufacture(59900-127)
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