Animal NDC 86127-002-02 Clx Derm Oto Plus

Chlorhexidine Gluconate

Animal Product Information

Field Name Field Value
Animal NDC Code 86127-002-02
Proprietary Name Clx Derm Oto Plus 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
    Oto plus Chlorhexidine digluconate ear cleanser for cats and dogs.
Active Ingredient(s)
  • Chlorhexidine Gluconate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • GLYCEROPHOSPHOINOSITOL LYSINE (X34K43QI7A)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • LACTOBIONIC ACID (65R938S4DV)
  • CAPRYLYL GLYCOL (00YIU5438U)
  • 1,2-HEXANEDIOL (TR046Y3K1G)
  • WATER (059QF0KO0R)
  • GLYCEROPHOSPHOINOSITOL LYSINE (X34K43QI7A)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • LACTOBIONIC ACID (65R938S4DV)
  • CAPRYLYL GLYCOL (00YIU5438U)
  • 1,2-HEXANEDIOL (TR046Y3K1G)
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.

Clx Derm Oto Plus 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



oto plus Chlorhexidine digluconate ear cleanser for cats and dogs.


Other



Properties: ClxDerm™ oto plus Chlorhexidine digluconate ear cleanser is an otic antiseptic solution designed for cleaning and moisturizing the ears of dogs and cats while providing a protective barrier against dirt and secretions that can attract bacteria. Contains moisturizers to help relieve itching. Chlorhexidine digluconate, the active ingredient in ClxDerm™ oto plus Chlorhexidine digluconate ear cleanser, has been proven effective against a broad-spectrum of micro-organisms sensitive to chlorhexidine. The use of ClxDerm™ oto plus will aid in the management of skin infections, supporting a healthy skin barrier.

Composition:

ACTIVE INGREDIENT(S):

Chlorhexidine digluconate 0.15%.

INACTIVE INGREDIENT(S):

1,2-Hexanediol, Caprylyl glycol, Fragrance, Glycerophosphoinositol lysine salt, Lactobionic acid, Propylene glycol, Purified water.

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]

To KNOW MORE
ABOUT
plus


Dosage & Administration



Directions for use: Apply a few drops of the product into each ear canal and then gently message the base of the ear to spread the solution. Allow the solution to remain in the ear for several minutes before removing. Then, use a clean cotton ball to remove dirt or waxy build-up. No need to rinse ears. Allow the ear to dry after each treatment. May be applied 1-2 times per week or as directed by your veterinarian.


Precautions



Precautionary statements:

For external use in the ear canals of dogs and cats only. May cause skin or eye irritation. Avoid getting solution in your pet's eyes. In case of contact with eyes, rinse thoroughly with water and consult a veterinarian. If skin irritation occurs and persists, discontinue use and contact your veterinarian. 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. Do not use in animals with damaged eardrums. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.


Safe Handling Warning



Warning: Keep out of reach of children.


Storage And Handling



Storage: Store at room temperature.

Do not freeze.


Principal Display Panel - 150 Ml Bottle Carton



CLXDerm™

oto plus

Chlorhexidine digluconate
ear cleanser
for cats and dogs

Developed in Italy

iCF™

Evolution of
Knowledge

5.07 fl. oz.(150 ml)


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