Animal NDC 86127-001-01 Clx Derm
Chlorhexidine Gluconate

Animal Product Information

Field Name Field Value
Animal NDC Code 86127-001-01
Proprietary Name Clx Derm 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
    ClxDerm™ 4% chlohexidinedigluconate antiseptic shampoofor dogs and cats
Active Ingredient(s)
  • Chlorhexidine Gluconate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • GUARAPROLOSE (3500 MPA.S AT 1%) (3A1I7376TC)
  • ISODECYL ALCOHOL (3160X491M7)
  • PEG-75 LANOLIN (09179OX7TB)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE SODIUM (MP1J8420LU)
  • MYRISTAMINE OXIDE (J086PM3RRT)
  • LAURAMINE OXIDE (4F6FC4MI8W)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • GUARAPROLOSE (3500 MPA.S AT 1%) (3A1I7376TC)
  • ISODECYL ALCOHOL (3160X491M7)
  • PEG-75 LANOLIN (09179OX7TB)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE SODIUM (MP1J8420LU)
  • MYRISTAMINE OXIDE (J086PM3RRT)
  • LAURAMINE OXIDE (4F6FC4MI8W)
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 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



ClxDerm™ 4% chlohexidine
digluconate antiseptic shampoo

for dogs and cats


Safe Handling Warning



Warning: Keep out of reach of children.


Properties:



ClxDerm™ 4% chlohexidine digluconate antiseptic shampoo designed for cleansing the skin of dogs and cats. Chlorhexidine, the active ingredient in ClxDerm™ shampoo 4%, has been proven effective against a broad-spectrum of micro-organisms sensitive to chlorhexidine. The use of ClxDerm™ 4% chlohexidine digluconate antiseptic shampoo will aid in the management of skin infections, supporting a healthy skin barrier.


Dosage & Administration



Directions for use: Wet your pet with warm water and apply shampoo. Massage into wet haircoat. Allow to remain on haircoat for 5-10 minutes before rinsing thoroughly with clean water. Repeat as needed. To improve skin condition, shampoo 1 to 2 times per week in a 1 to 2 week period, or as directed by your veterinarian. To maintain healthy skin, shampoo at least once per month or as directed by your veterinarian.


Precautionary Statements:



For external use on dogs and cats only. May cause skin or eye irritation. Avoid getting shampoo 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. 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.


Active Ingredient(S):



Chlorhexidine digluconate 4%.


Other



Inactive ingredient(s): deionized water, fragrance, glycerin, hydroxypropyl guar, isodecyl alcohol ethoxylate, lanolin ethoxylated, lauramine oxide, myristamine oxide propylene glycol, Tris-EDTA.

www.icfpet.com

Manufacturer:

iCF™
Evolution
of
Knowledge

a division of nextmune

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


Indications:



For use on dogs and cats only to maintain healthy skin and hair and to enhance hygiene. Aids in the management of skin infections associated with micro-organisms that are sensitive to chlorhexidine.


Principal Display Panel - 250 Ml Bottle Carton



CLXDerm™

4%
chlohexidine
digluconate

Antiseptic shampoo
for dogs and cats

Developed in Italy

iCF™
Evolution of
Knowledge

8.45 fl. oz.(250 ml)


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