ZN4.5 OTIC- zinc gluconate solution

Zn4.5 Otic by

Drug Labeling and Warnings

Zn4.5 Otic by is a Animal medication manufactured, distributed, or labeled by H&C Animal Health, Addison Biological Laboratory, Inc., Jost Chemical Co., Alliance Analytical Laboratories, Inc., ADAMSON ANALYTICAL LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS:

A natural, complexed zinc and amino acid, non-staining ear care formula for pets.  Helps eliminate odor-causing bacteria.  Nourishes and replenishes the ear tissue.  

INFORMATION FOR OWNERS/CAREGIVERS

• Natural Complexed Zinc and Amino Acid formula.  
• Creates a Healthy Environment in the Ear.
• Non-Staining
• Safe for Daily Use

WARNINGS

Keep out of reach of children.  

INSTRUCTIONS FOR USE

DIRECTIONS:

Fill cleansed ear canal with Zn4.5Otic, massage base of ear canal. Subsequent applications, apply 5-8 drops daily.  If irritation increases, discontinue use and consult your veterinarian. Regular ear exams by veterinarian is recommended.  

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

MAINTENANCE:

Apply product as above 2-3 times per week.  Ears should be regularly evaluated by a veterinarian.  

INACTIVE INGREDIENT

INGREDIENTS: 

Deionized Water, Zinc Gluconate, Boric Acid, L-Lysine, Propylene Glycol, Taurine, Methylparaben, Propylparaben.  

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

Package label, display panel

MAXI/GUARD®
Zn4.5Otic®
Natural Complexed Zinc and Amino Acid formula.
Creates a Healthy Environment in the Ear.
Non-Staining
Safe for Daily Use
2 FL. OZ. (59mL)
FEATURES:
A natural, complexed zinc and amino acid, non-staining ear care formula for pets. Helps eliminate odor-causing bacteria. Nourishes and replenishes the ear tissue. Nourishes and replenishes
DIRECTIONS:
Fill cleansed ear canal with Zn4.5Otic, massage base of ear canal. Subsequent applications, apply 5-8 drops daily. If irritation increases, discontinue use and consult your veterinarian. Regular ear exams by veterinarian is recommended.
MAINTENANCE:
Apply product as above 2-3 times per week. Ears should be regularly evaluated by a veterinarian.
INGREDIENTS:
Deionized Water, Zinc Gluconate, Boric Acid,
L-Lysine, Propylene Glycol,
Taurine, Methylparaben, Propylparaben.
KEEP OUT OF REACH OF CHILDREN.
DISTRIBUTED BY H&C ANIMAL HEALTH , LLC.
Addison Biological Laboratory, Inc.
507 North Cleveland Avenue
Fayette, Missouri 65248 U.S.A.
www.addisonlabs.com
Rev. 04/20

Package label , display panel

MAXI/GUARD®
Zn4.5Otic®
Natural Complexed Zinc and Amino Acid formula.
Creates a Healthy Environment in the Ear.
Non-Staining
Safe for Daily Use
4 FL. OZ. (118mL)
FEATURES:
A natural, complexed zinc and amino acid, non-staining ear care formula for pets. Helps eliminate odor-causing bacteria. Nourishes and replenishes the ear tissue. Nourishes and replenishes
DIRECTIONS:
Fill cleansed ear canal with Zn4.5Otic, massage base of ear canal. Subsequent applications, apply 5-8 drops daily. If irritation increases, discontinue use and consult your veterinarian. Regular ear exams by veterinarian is recommended.
MAINTENANCE:
Apply product as above 2-3 times per week. Ears should be regularly evaluated by a veterinarian.
INGREDIENTS:
Deionized Water, Zinc Gluconate, Boric Acid,
L-Lysine, Propylene Glycol,
Taurine, Methylparaben, Propylparaben.
KEEP OUT OF REACH OF CHILDREN.
DISTRIBUTED BY H&C ANIMAL HEALTH , LLC.
Addison Biological Laboratory, Inc.
507 North Cleveland Avenue
Fayette, Missouri 65248 U.S.A.
www.addisonlabs.com
Rev. 04/20

INGREDIENTS AND APPEARANCE

ZN4.5 OTIC 
zinc gluconate solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86137-7609
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	.011 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TAURINE (UNII: 1EQV5MLY3D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LYSINE (UNII: K3Z4F929H6)
BORIC ACID (UNII: R57ZHV85D4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86137-7609-0	59 mL in 1 PACKAGE
2	NDC: 86137-7609-1	118 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Alliance Analytical Laboratories, Inc.		007588338	analysis

Establishment
Name	Address	ID/FEI	Business Operations
ADAMSON ANALYTICAL LABORATORIES INC		944399906	analysis