Label: BREATH FRIEND- zinc gluconate gel

  • NDC Code(s): 86045-3200-1
  • Packager: Addison Biological Laboratory, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 2, 2023

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  • INFORMATION FOR OWNERS/CAREGIVERS

    Benefits: Natural 1-step oral cleansing action without brushing, instant fresh breath, superior pet acceptance.

  • INSTRUCTIONS FOR USE

    Directions: Apply gel directly on the gums above the outside of the back molars. One drop placed on the index finger and applied on each side of the mouth will give optimum pet acceptance in adult cats. Use slightly more for small dogs. Most medium to large dogs will accept direct application from the built-in applicator tip.

    A natural cleansing action will distribute the gel to remote areas of the mouth.  Use daily for best results.

  • STORAGE AND HANDLING

    Storage: Store at room temperature and keep out of direct sunlight. 

  • SPL UNCLASSIFIED SECTION

    Ingredients: Deionized water, Carboxymethylcellulose, Zinc gluconate, Taurine, Methylparaben, Propylparaben, F.D.&C. Blue #1.

  • WARNINGS

    Keep out of reach of children.  

  • SPL UNCLASSIFIED SECTION

    Addison Biological Laboratory, Inc. 

    507 North Cleveland Avenue

    Fayette, Missouri 65248 U.S.A.

    www.addisonlabs.com

    MADE IN THE U.S.A.

    Rev. 09/11

  • PRINCIPAL DISPLAY PANEL

    Cleanses and Freshens Without Brushing

    Breath Friend®

    Alcohol Free
    Chlorhexidine Free
    Taste Free
    2 FL. OZ. (59ml)

    Benefits: Natural 1-step oral cleansing action without brushing, instant fresh breath, superior pet acceptance.

    Directions: Apply gel directly on the gums above the outside of the back molars. One drop placed on the index finger and applied on each side of the mouth will give optimum pet acceptance in adult cats. Use slightly more for small dogs. Most medium to large dogs will accept direct application from the built-in applicator tip.

    A natural cleansing action will distribute the gel to remote areas of the mouth. Use daily for best results.

    Storage: Store at room temperature and keep out of direct sunlight.

    Ingredients: Deionized water, Carboxymethylcellulose, Zinc gluconate, Taurine, Methylparaben, Propylparaben, F.D.&C. Blue #1.

    Keep out of reach of children.

    Addison Biological Laboratory, Inc.

    507 North Cleveland Avenue

    Fayette, Missouri 65248 U.S.A.

    www.addisonlabs.com

    MADE IN THE U.S.A.

    Rev. 04/16

    label

  • INGREDIENTS AND APPEARANCE
    BREATH FRIEND 
    zinc gluconate gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86045-3200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE.0165 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TAURINE (UNII: 1EQV5MLY3D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86045-3200-159 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2001
    Labeler - Addison Biological Laboratory, Inc. (118396730)
    Registrant - Addison Biological Laboratory, Inc. (118396730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Addison Biological Laboratory, Inc.118396730manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Jost Chemical Co.147882294api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ADAMSON ANALYTICAL LABORATORIES INC944399906analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliance Analytical Laboratories, Inc.007588338analysis