Label: SOFTONE LUXURY FOAM ANTIBACTERIAL SKIN CLEANSER- triclosan solution

  • 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 September 26, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Triclosan Liquid 0.5% w/w

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For External Use Only.

    When using this product avoid contact with eyes; in case of contact, flush eyes with water.

    Stop use & ask a doctor if irritation or redness develops and persists.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Wet hands and apply a palmful to hands. Scrub thoroughly for 15-20 seconds. Rinse and dry thoroughly.

  • Other Information

    • Report serious side effects from this product to 1-877-561-6587
  • Ingredients

    Water, Propylene Glycol, Sodium Citrate, Sodium Cumenesulfonate, Sodium Laureth Sulfate, Citric Acid, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone

  • Questions?

    1-888-346-4652

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by Brady Industries,
    LLC Las Vegas, NV 89118

  • PRINCIPAL DISPLAY PANEL - 1 Liter Container Label

    BRADY

    Softone

    LUXURY FOAM ANTIBACTERIAL
    SKIN CLEANSER

    Intended for use in restrooms
    and non-processing areas only.

    1 Liter
    (33.8 fl oz)

    NSF®

    Nonfood Compounds
    Program Listed E4
    144823

    CM1554

    Triclosan Liquid 0.5%

    20-14-580-0-00 / 29617

    Principal Display Panel - 1 Liter Container Label
  • INGREDIENTS AND APPEARANCE
    SOFTONE LUXURY FOAM ANTIBACTERIAL SKIN CLEANSER 
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76279-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan5 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Sodium Cumenesulfonate (UNII: 5798KA13PG)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    PEG-7 Glyceryl Cocoate (UNII: VNX7251543)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76279-420-121.2 L in 1 CONTAINER
    2NDC:76279-420-101 L in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E10/01/2011
    Labeler - Brady Industries LLC (034932657)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!