Animal NDC 86127-009-03 Otodine
Chlorhexidine Gluconate

Animal Product Information

Field Name Field Value
Animal NDC Code 86127-009-03
Proprietary Name Otodine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Chlorhexidine Gluconate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Nextmune Ab
Product Type Otc Animal Drug
Usage Information
    Ear cleaning chlorhexidine digluconate solution to remove excess ear wax in dogs and cats
Active Ingredient(s)
  • Chlorhexidine Gluconate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ERYTHRITOL (RA96B954X6)
  • PROPANEDIOL (5965N8W85T)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE SODIUM (MP1J8420LU)
  • 1,2-HEXANEDIOL (TR046Y3K1G)
  • CAPRYLYL GLYCOL (00YIU5438U)
  • WATER (059QF0KO0R)
  • ERYTHRITOL (RA96B954X6)
  • PROPANEDIOL (5965N8W85T)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE SODIUM (MP1J8420LU)
  • 1,2-HEXANEDIOL (TR046Y3K1G)
  • CAPRYLYL GLYCOL (00YIU5438U)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Otodine Images

Otodine Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Other



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

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:[email protected]
[email protected]


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.


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)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.