Label: TRIS-NAC- acetylcysteine solution
- NDC Code(s): 86127-011-07
- Packager: Nextmune AB
- Category: OTC ANIMAL DRUG LABEL
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Drug Label Information
Updated May 13, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- WARNINGS
- STORAGE AND HANDLING
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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.
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SPL UNCLASSIFIED SECTION
Distributor:
nextmuneNextmune US, LLC
2801 S. 35th St., Phoenix,
AZ 85034 - 480-464-8971Made
in GermanyManufacturer
icf™
Evolution of
Knowledge
a division of nextmuneNEXTMUNE 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
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INGREDIENTS AND APPEARANCE
TRIS-NAC
acetylcysteine solutionProduct 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