CLX DERM SPOT- chlorhexidine gluconate gel

Clx Derm Spot by

Drug Labeling and Warnings

Clx Derm Spot 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

chlorhexidine digluconate antiseptic skin gel for dogs and cats.

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.

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

CLX DERM SPOT 
chlorhexidine gluconate gel

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)
isodecyl alcohol (UNII: 3160X491M7)
Sorbitol (UNII: 506T60A25R)
PEG-75 Lanolin (UNII: 09179OX7TB)
TROMETHAMINE (UNII: 023C2WHX2V)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-004-03	1 in 1 CARTON
1		100 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