CLX DERM- chlorhexidine gluconate shampoo

CLX Derm by

Drug Labeling and Warnings

CLX Derm by is a Animal medication manufactured, distributed, or labeled by Nextmune AB, ICF SRL, Medichem SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Composition:

Active ingredient(s):

Chlorhexidine digluconate 4%.

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

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.

SPL UNCLASSIFIED SECTION

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:info@icfsrl.it
customercare@drnsrl.it

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

made
in Spain

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)

INGREDIENTS AND APPEARANCE

CLX DERM 
chlorhexidine gluconate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)
isodecyl alcohol (UNII: 3160X491M7)
PEG-75 Lanolin (UNII: 09179OX7TB)
TROMETHAMINE (UNII: 023C2WHX2V)
EDETATE SODIUM (UNII: MP1J8420LU)
MYRISTAMINE OXIDE (UNII: J086PM3RRT)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-001-01	1 in 1 CARTON
1		250 mL in 1 BOTTLE, PLASTIC

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	Business Operations
NEXTMUNE Italy SRL		435856461	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Medichem SA		464043381	API MANUFACTURE