ORAZN- zinc gluconate gel

OraZn by

Drug Labeling and Warnings

OraZn by is a Animal medication manufactured, distributed, or labeled by H&C Animal Health, Addison Biological Laboratory, Inc., Jost Chemical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INFORMATION FOR OWNERS/CAREGIVERS

Benefits: Natural oral cleansing without brushing, instant fresh breath, Easy application & taste free. Pet Accepted, Vet Approved.

INSTRUCTIONS FOR USE

Directions: Apply gel directly to gums above the back upper teeth. Cleansing action will naturally spread to other 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

DISTRIBUTED BY H&C ANIMAL HEALTH, LLC.

MADE IN THE U.S.A.

Addison Biological Laboratory, Inc. 

507 North Cleveland Avenue

Fayette, Missouri 65248 U.S.A.

www.addisonlabs.com

Rev. 04/20

Principal Display Panel - OraZn

PET DENTAL CARE GEL
OraZn®

Powerful Neutralized Zinc Cleanses & Freshens
Without Brushing
Taste Free
Natural Formula
2 FL. OZ (59ml)

Benefits: Natural oral cleansing without brushing, instant fresh breath, Easy application & taste free. Pet Accepted, Vet Approve
Directions: Apply gel directly to gums above the back upper teeth. Cleansing action will naturally spread to other 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.

DISTRIBUTED BY H&C ANIMAL HEALTH, LLC.
MADE IN THE U.S.A.
Addison Biological Laboratory, Inc.
507 North Cleveland Avenue
Fayette, Missouri 65248 U.S.A.
www.addisonlabs.com
Rev. 04/20

INGREDIENTS AND APPEARANCE

ORAZN 
zinc gluconate gel

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86137-4409
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	.0165 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TAURINE (UNII: 1EQV5MLY3D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86137-4409-0	12 in 1 BOX
1		59 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2001

Labeler - H&C Animal Health (080739405)

Registrant - Addison Biological Laboratory, Inc. (118396730)

Establishment
Name	Address	ID/FEI	Business Operations
Addison Biological Laboratory, Inc.		118396730	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Jost Chemical Co.		147882294	api manufacture