OTODINE- chlorhexidine gluconate solution

Otodine by

Drug Labeling and Warnings

Otodine by is a Animal medication manufactured, distributed, or labeled by Nextmune AB, NEXTMUNE Italy SRL, Medichem SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Ear cleaning chlorhexidine digluconate solution to remove excess ear wax in dogs and cats

Active Ingredient(s):

Chlorhexidine digluconate 0.15%.

Inactive Ingredient(s):

1,2-Hexanediol; Caprylyl Glycol, deionized water; erythritol; propanediol; Tris-EDTA.

INDICATIONS & USAGE

Indications: For cleaning and removal of excess cerumen (ear wax) in dogs and cats.

SPL UNCLASSIFIED SECTION

Properties: The active ingredient(s) in Otodine™ provide an effective cleansing action which helps to remove excess ear wax.

Directions for use:

Flood the ear canal with the cleaning solution. Gently message the ear canal to break up wax and debris. Using a cotton ball, remove any excess solution left in the ear. Otodine may be used 1 to 2 times a day. The solution will also clean the ear flap and surrounding skin of the ear. Do not rinse.

Precautionary statements:

For use in the ears of dogs and cats only. May cause eye irritation. Consult a veterinarian before using on pregnant, lactating or breeding animals; puppies; kittens; or animals with a pre-existing medical condition. Use with caution in older animals. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.

STORAGE AND HANDLING

Storage: Store at room temperature. Do not freeze.

SAFE HANDLING WARNING

Warning: Keep out of reach of children.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

iCF™
Evolution of
Knowledge
www.icfpet.com

Distributor:

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

Made
in Spain

Manufacturer:

iCF™
Evolution of
Knowledge

a division of

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 - 100 ml Bottle Carton

Otodine™

Ear
cleaning

Chlorhexidine digluconate
solution to remove
excess ear wax

in cats and dogs

Developed in Italy

iCF™
Evolution of
Knowledge

3.38 fl. oz.(100 ml)

INGREDIENTS AND APPEARANCE

OTODINE 
chlorhexidine gluconate solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-009
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
erythritol (UNII: RA96B954X6)
propanediol (UNII: 5965N8W85T)
Tromethamine (UNII: 023C2WHX2V)
Edetate Sodium (UNII: MP1J8420LU)
1,2-Hexanediol (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-009-03	1 in 1 CARTON
1		100 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2021

Labeler - Nextmune AB (352950223)

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

Establishment
Name	Address	ID/FEI	Business Operations
Medichem SA		464043381	API MANUFACTURE