Label: TRI-SOFT SOFTENING- benzalkonium chloride solution

  • NDC Code(s): 44577-711-08
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • TRI-SOFT SOFTENING SOLUTION


  • Active Ingredient

    BENZALKONIUM CHLORIDE (0.13 %)

  • Purpose

    Antiseptic

  • Uses:

    For antiseptic cleansing that will decrease bacteria on the skin without soap and water.


  • Warnings

    For external use only.

    Do not use in the eyes. If eye contact occurs, rinse thoroughly with water.

    Stop use and consult a physician if irritation or redness develops and persists for more than 72 hours.

    Do not bandage tightly.

    If pregnant or breast feeding, contact physician prior to use.

  • Keep out of reach of children

    if swallowed, consult physician or poison control immediately

  • Directions

    Mix 1 part Tri-Soft Concentrate with water q. s. to 16 parts. Saturate cotton and place over hyperkeratotic tissues for 3 minutes before reduction or debridement.

  • Other Ingredients

    Aqua (Deionized Water), Benzyl Alcohol, Phenylmercuric Nitrate, Polysorbate-20, SD-Alcohol 40B.

  • SPL UNCLASSIFIED SECTION

    Tri-Soft Softening Solution is a rapid-acting emulsifying agent combined with antiseptic properties.

    It is specifically formulated for use on the skin prior to instrument reduction of hyperkeratotic lesions.




  • TRI-SOFT SOFTENING SOLUTION 8oz (44577-711-08)

    TRISOFT

  • INGREDIENTS AND APPEARANCE
    TRI-SOFT SOFTENING 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENYLMERCURIC NITRATE (UNII: CG8692ZN14)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-711-08236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product02/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/06/2012
    Labeler - Clinical Therapeutic Solutions (078402750)
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