Label: STOMODINE F- chlorhexidine gluconate gel

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 12, 2022

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  • 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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    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 lb0.39
    --11 to 33 lb 0.78
    --33 to 72 lb1.18
    --> 72 lb1.54
  • 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)

    Principal Display Panel - 30 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    STOMODINE F 
    chlorhexidine gluconate gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-010-061 in 1 CARTON
    130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2021
    Labeler - Nextmune AB (352950223)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXTMUNE Italy SRL435856461MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Medichem SA464043381API MANUFACTURE
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