STOMODINE F- chlorhexidine gluconate gel

Stomodine F by

Drug Labeling and Warnings

Stomodine F by is a Animal medication manufactured, distributed, or labeled by Nextmune AB, NEXTMUNE Italy SRL, Medichem SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Stomodine™F Chlorhexidine digluconate plaque prevention gel for dogs and cats

SPL UNCLASSIFIED SECTION

Active ingredient(s): chlorhexidine digluconate 0.2%.

SPL UNCLASSIFIED SECTION

Inactive ingredient(s): cetylpyridinium chloride monohydrate, deionized water, EDTA, ethylhexylglycerin, erythritol, glycerin, hydroxypropyl guar, phytosphingosine, polysorbate 20, preservative (phenoxyethanol), sorbitol, Tris.

VETERINARY INDICATIONS

Indications: To slow the formation of dental plaque and reduce bad breath. Promotes good oral hygiene.

DOSAGE & ADMINISTRATION

Directions for use: Between meals, apply the gel between the lips and gums using the special applicator, and lightly message. Apply 1-2 times a day for 15-20 days following your veterinarian's recommendations. Can be used following tooth scaling or dental extractions.

PRECAUTIONS

Precautionary statements: For oral use in dogs and cats only. 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. Use before the expiration date provided on the tube.

SAFE HANDLING WARNING

Warning: Keep out of reach of children.

SPL UNCLASSIFIED SECTION

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at videos

www.icfpet.com

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

Made
in Spain

SPL UNCLASSIFIED SECTION

The amount dispensed is based on the following table:

Application Table

For Cats weighing…	For Dogs weighing…	Length (line of gel)(inches)
All sizes	≤ 11 lb	0.39
--	11 to 33 lb	0.78
--	33 to 72 lb	1.18
--	> 72 lb	1.54

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

Stomodine™ F
Chlorhexidine digluconate
plaque prevention gel for dogs and cats

Developed in Italy

1.01 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

STOMODINE F 
chlorhexidine gluconate gel

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ERYTHRITOL (UNII: RA96B954X6)
GLYCERIN (UNII: PDC6A3C0OX)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITOL (UNII: 506T60A25R)
TROMETHAMINE (UNII: 023C2WHX2V)
GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-010-06	1 in 1 CARTON
1		30 mL in 1 TUBE

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