Label: MAXI/GUARD ORAL CLEANSING GEL- zinc gluconate gel

  • NDC Code(s): 86137-4109-0
  • Packager: H & C Animal Health LLC
  • 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.

  • INDICATIONS & USAGE

    Zinc + Vitamin C: Freshens breath & cleanses the mouth by reducing odor-causing bacteria. Pet Accepted & Vet Approved.

    Directions: Pour contents of small vial ( Vitamin C) into large bottle. Close bottle and allow Vitamin C to drop to the bottom. Shake until dissolved. Apply a pea -sized ( more for medium/large dogs) on your finger or finger brush and apply above the upper back teeth on each side of the mouth. Cleansing action will naturally spread to other areas of the mouth. Use daily for best results.

  • STORAGE AND HANDLING

    STORAGE: Keep out of direct sunlight. Securely close applicator tip after each use. Mixed product should be refridgerated for maximum shelf life.

    Color indiator: Blue/Green  = Fresh , Yellow or brown = expired.

  • INACTIVE INGREDIENT

    INGREDIENTS: Deionized Water, Zinc Gluconate, Ascorbic Acid (Vitamin C), Taurine, Xanthan Gum, Methylparaben, Propylparaben, F.D.&C. Blue #1

  • OTHER SAFETY INFORMATION

    KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY H&c ANIMAL HEALTH, LLC.

    Made in the U.S.A.

    Addison Biological Laboratory, Inc.

    507 North Cleveland Avenue
    Fayette, Missouri 65248
    www.addisonlabs.com

    Rev. 04/20

  • Package label, display panel

    MAXI GUARD 

    DENTAL CLEANSING GEL

    • Natural Zinc & Vitamin C Formula
    • Cleans Teeth & Freshens Breath
    • Works with or Without Brushing
    • Chlorhexidine Free

    4fl.oz. ( 118 mL)

    Zinc + Vitamin C: Freshens breath & cleanses the mouth by reducing odor-causing bacteria. Pet Accepted & Vet Approved.

    Directions: Pour contents of small vial ( Vitamin C) into large bottle. Close bottle and allow Vitamin C to drop to the bottom. Shake until dissolved. Apply a pea -sized ( more for medium/large dogs) on your finger or finger brush and apply above the upper back teeth on each side of the mouth. Cleansing action will naturally spread to other areas of the mouth. Use daily for best results.

    STORAGE: Keep out of direct sunlight. Securely close applicator tip after each use. Mixed product should be refridgerated for maximum shelf life.

    Color indiator: Blue/Green = Fresh , Yellow or brown = expired.

    INGREDIENTS: Deionized Water, Zinc Gluconate, Ascorbic Acid (Vitamin C), Taurine, Xanthan Gum, Methylparaben, Propylparaben, F.D.&C. Blue #1

    KEEP OUT OF REACH OF CHILDREN

    DISTRIBUTED BY H&C ANIMAL HEALTH, LLC.

    Made in the U.S.A.

    Addison Biological Laboratory, Inc.

    507 North Cleveland Avenue
    Fayette, Missouri 65248
    www.addisonlabs.com

    Rev. 04/20

    image description

  • INGREDIENTS AND APPEARANCE
    MAXI/GUARD ORAL CLEANSING GEL 
    zinc gluconate gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86137-4109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE0.022 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TAURINE (UNII: 1EQV5MLY3D)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86137-4109-0118 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/04/2014
    Labeler - H & C Animal Health LLC (080739405)
    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