Label: ORAZN- zinc gluconate gel

  • NDC Code(s): 86045-3300-1
  • 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

If you are a consumer or patient please visit this version.

  • INFORMATION FOR OWNERS/CAREGIVERS

    Features: Easy applicator tip, taste free formulation, and neutralized zinc cleansing.

    Benefits: Natural oral cleansing without brushing, instant fresh breath, and superior pet acceptance.

  • INSTRUCTIONS FOR USE

    Directions: Apply gel directly to the outside gums above the back upper molars. One drop placed on your index finger, swab, or fingerbrush and applied on each side of the mouth will provide 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. 

  • ACTIVE INGREDIENT

    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. 06/17

  • Principle Display Panel - OraZn

    Cleanses & Freshens
    Without Brushing
    OraZn®
    Pet
    Oral
    Care


    Neutralized Zinc

    • Taste Free
    • Natural Formula

    2 FL. OZ (59ml)

    MAXI/GUARD®

    Features: Easy applicator tip, taste free formulation, and neutralized zinc cleansing.
    Benefits: Natural oral cleansing without brushing, instant fresh breath, and superior pet acceptance.
    Directions: Apply gel directly to the outside gums above the back upper molars. One drop placed on your index finger, swab, or fingerbrush and applied on each side of the mouth will provide 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. 06/17

    image description

  • INGREDIENTS AND APPEARANCE
    ORAZN 
    zinc gluconate gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86045-3300
    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:86045-3300-112 in 1 BOX
    159 mL in 1 BOTTLE
    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