Label: SOFTEN SURE FOAM ANTIMICROBIAL- chloroxylenol liquid

  • NDC Code(s): 59900-211-06, 59900-211-10, 59900-211-11
  • Packager: Best Sanitizers, 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 January 4, 2019

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  • Active Ingredient

    Chloroxylenol 1.0%

  • Purpose

    Antimicrobial Hand Cleanser

  • Uses

    • Handwash to help reduce bacteria that potentially can cause diseases
    • Helps to prevent cross contaminiation 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.
  • Keep out of reach of children

    In case of accidental ingestion seek medical attention or contact a poison center immediately.

  • Directions

    • Wet hands and forearms
    • Apply an application to hands and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse
  • Other Information

    • Store in a cool dry place below 104° F
  • Inactive ingredients

    purified water, potassium cocoate, tetrasodium EDTA, FDC No. 1, Yellow No.5, fragrance

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 59900-211-06

    NDC 59900-211-10

    NDC 59900-211-11

    Soften Sure Foam Soap antimicrobial

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SOFTEN SURE FOAM ANTIMICROBIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL10 g  in 1000 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:59900-211-061000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2008
    2NDC:59900-211-10500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2008
    3NDC:59900-211-111000 mL in 1 BAG; Type 0: Not a Combination Product09/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2008
    Labeler - Best Sanitizers, Inc (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture(59900-211)
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