Otodine: Product Information

OTODINE- chlorhexidine gluconate 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.

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

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: Store at room temperature. Do not freeze.

Warning: Keep out of reach of children.

ImageImageImage

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)

PRINCIPAL DISPLAY PANEL -- 100 ml Bottle Carton
(click image for full-size original)
OTODINE chlorhexidine gluconate solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86127-009
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
erythritol
propanediol
Tromethamine
Edetate Sodium
1,2-Hexanediol
Caprylyl Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86127-009-03 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (86127-009-03)
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 Operations
NEXTMUNE Italy SRL 435856461 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Medichem SA 464043381 API MANUFACTURE

Revised: 01/2022 Nextmune AB

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2024. All Rights Reserved.