TRIS-NAC- acetylcysteine solution 
Nextmune AB

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.

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Tris-NAC™

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

Active ingredient(s):

N-Acetylcysteine 1.35 %.

Inactive ingredient(s):

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

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:

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

How to use:

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.

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
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

Revised: 5/2022
Document Id: 0fa2a62d-24ea-43dc-afb0-f8cd749cbcbd
Set id: 9fe6280b-c788-48b5-82c9-027618bb4b0f
Version: 1
Effective Time: 20220513
 
Nextmune AB