TRIS-NAC- acetylcysteine solution

Tris-NAC by

Drug Labeling and Warnings

Tris-NAC by is a Animal medication manufactured, distributed, or labeled by Nextmune AB, NEXTMUNE Italy SRL, PharmaZell GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

TRIS-NAC 
acetylcysteine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)	ACETYLCYSTEINE	1.35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-011-07	1 in 1 CARTON
1		120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/01/2022

Labeler - Nextmune AB (352950223)

Establishment
Name	Address	ID/FEI	Business Operations
NEXTMUNE Italy SRL		435856461	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
PharmaZell GmbH		506639652	API MANUFACTURE