Animal NDC 86127-004-03 Clx Derm Spot

Chlorhexidine Gluconate

Animal Product Information

Field Name Field Value
Animal NDC Code 86127-004-03
Proprietary Name Clx Derm Spot 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
    Chlorhexidine digluconate antiseptic skin gel for dogs and cats.
Active Ingredient(s)
  • Chlorhexidine Gluconate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • GUARAPROLOSE (3500 MPA.S AT 1%) (3A1I7376TC)
  • ISODECYL ALCOHOL (3160X491M7)
  • SORBITOL (506T60A25R)
  • PEG-75 LANOLIN (09179OX7TB)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE SODIUM (MP1J8420LU)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • GUARAPROLOSE (3500 MPA.S AT 1%) (3A1I7376TC)
  • ISODECYL ALCOHOL (3160X491M7)
  • SORBITOL (506T60A25R)
  • PEG-75 LANOLIN (09179OX7TB)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE SODIUM (MP1J8420LU)
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 Spot 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



chlorhexidine digluconate antiseptic skin gel for dogs and cats.


Otc - Active Ingredient



Active ingredient(s):

Chlorhexidine digluconate 0.45%


Inactive Ingredient



Inactive ingredient(s): deionized water, glycerin, hydroxypropyl guar, isodecanol ethoxylated, lanolin ethoxylated, sorbitol, Tris-EDTA.


Indications & Usage



Indications: For topical use on dogs and cats only to aid in the management of skin infections associated with micro-organisms that are sensitive to chlorhexidine.


Dosage & Administration



Directions for use: Apply topically to affected spots on the skin. Apply 2-3 times per day until skin improves or as directed by your veterinarian. Then, reduce application to weekly. Do not rinse product after application.


Precautions



Precautionary statements:

For external use on dogs and cats only. May cause skin or eye irritation. Avoid getting gel 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 inside the ear canal. 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.


Other



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]

Distributor:

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

Made
in Spain

iCF™
Evolution
of
Knowledge

www.icfpet.com


Principal Display Panel - 100 Ml Bottle Carton



CLXDerm™

spot gel

chlorhexidine digluconate
antiseptic skin gel

for dogs and cats

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.