Label: TRIS-NAC- acetylcysteine solution

  • Category: OTC ANIMAL DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 13, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    N-ACETYLCYSTEINE ANTIBACTERIAL solution with high ionic strength for dogs and cats.

  • SPL UNCLASSIFIED SECTION

    Active ingredient(s):

    N-Acetylcysteine 1.35 %.

  • SPL UNCLASSIFIED SECTION

    Inactive ingredient(s):

    deionized water, EDTA, ethylhexylglycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, silica, Tris.

  • INDICATIONS & USAGE

    Indications:

    Tris-NAC™ is an innovative and synergistic combination of NAC and Tris-EDTA to be applied as an effective support to prevent bacterial biofilm formation. Where a mature biofilm already exists, Tris-NAC™ works to disrupt it and break it down.

  • WARNINGS

    Warnings:

    • For external use only, not indicated for oral use.
    • Store the unopened bottle at room temperature and keep away from sunlight.
    • Keep out of reach of children.
    • Dispose of empty bottle properly.
  • STORAGE AND HANDLING

    Shelf life of the reconstituted suspension in a refrigerator (36° to 46°F): 2 months

  • DOSAGE & ADMINISTRATION

    How to use:

    • Unscrew the cap from the bottle.
    • Insert other cap, after removing silver film.
    • Fully press so that powder can be dispensed in the bottle.
    • Shake well the bottle.
    • Using syringe (contained in the pack), withdraw from the bottle the quantity as described below or as your veterinarian directs.

    In the ear canal: dispense the contents of the syringe into the ear canal and gently massage the base of the ear. On the skin: soak a sterile gauze with the product and hold the gauze to the skin for at least 2 minutes. In the case of larger areas, put the product directly on the skin until completely soaked. In both cases, do not rinse or dry. Repeat the application when necessary, or as your veterinarian directs.

    See the package leaflet for further information.

  • SPL UNCLASSIFIED SECTION

    Distributor:
    nextmune

    Nextmune US, LLC
    2801 S. 35th St., Phoenix,
    AZ 85034 - 480-464-8971

    Made
    in Germany

    Manufacturer
    icf
    Evolution of
    Knowledge
    a division of nextmune

    NEXTMUNE ITALY S.R.L.
    Via G.B. Benzoni, 50 26020
    PALAZZO PIGNANO (CR) Italy
    Tel. +39 0373 982024 +39 0373 938345
    e-mail: info@icfsrl.it - customercare@drnsrl.it

  • PRINCIPAL DISPLAY PANEL - 120 ml Bottle Carton

    Tris-NAC™

    Solution

    N-ACETYLCYSTEINE
    ANTIBACTERIAL
    solution with high
    ionic strength

    for dogs and cats

    Developed in Italy

    icf™
    Evolution of
    Knowledge

    4.05 fl. oz. (120 ml)

    PRINCIPAL DISPLAY PANEL - 120 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TRIS-NAC 
    acetylcysteine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE1.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETIC ACID (UNII: 9G34HU7RV0)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-011-071 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/01/2022
    Labeler - Nextmune AB (352950223)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXTMUNE Italy SRL435856461MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    PharmaZell GmbH506639652API MANUFACTURE