ZN4.5OTIC- zinc gluconate solution

Zn4.5Otic by

Drug Labeling and Warnings

Zn4.5Otic by is a Animal medication manufactured, distributed, or labeled by 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, non-staining ear care formula for pets.  Helps eliminate odor-causing bacteria.  Nourishes and replenishes the ear epithelium.  

INFORMATION FOR OWNERS/CAREGIVERS

Complexed zinc and amino acid formula.  

WARNINGS

Keep out of reach of children.  

INSTRUCTIONS FOR USE

DIRECTIONS:

Cleanse ear canal with suitable cleanser.  Fill ear canal with Zn4.5Otic, massage base of ear canal.  For subsequent applications, apply 5-8 drops daily.  If undue irritation develops or increases, discontinue use and consult your veterinarian.  

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

MAINTENANCE:

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

SPL UNCLASSIFIED SECTION

INGREDIENTS: 

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

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. 05/13

PRINCIPAL DISPLAY PANEL

MAXI/GUARD®

Zn4.5Otic®

A Natural

Ear Care Solution

Delivering

Complexed Zinc™

2 FL. OZ. (59mL)

INDICATIONS:

A natural, complexed zinc,

non-staining ear care formula

for pets. Helps eliminate

odor-causing bacteria.

Nourishes and replenishes

the ear epithelium.

Complexed zinc and amino

acid formula.

Keep out of reach of children.

DIRECTIONS:

Cleanse ear canal with suitable cleanser.

Fill ear canal with Zn4.5Otic®, massage

base of ear canal. For subsequent

applications, apply 5-8 drops daily. If

undue irritation develops or increases,

discontinue use and consult your

veterinarian.

MAINTENANCE:

Apply product as above 2-3 times per

week. Ears should be evaluated by a

veterinarian on a regular basis.

INGREDIENTS:

Deionized Water, Zinc Gluconate, Boric Acid,

L-Lysine, Propylene Glycol,

Taurine, Methylparaben, Propylparaben.

Addison Biological Laboratory, Inc.
507 North Cleveland Avenue
Fayette, Missouri 65248 U.S.A.
www.addisonlabs.com
MADE IN THE U.S.A.
Rev. 07/17

INGREDIENTS AND APPEARANCE

ZN4.5OTIC 
zinc gluconate solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86045-5000
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: 86045-5000-2	59 mL in 1 PACKAGE
2	NDC: 86045-5000-3	118 mL in 1 PACKAGE
3	NDC: 86045-5000-1	29.5 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2003

Labeler - Addison Biological Laboratory, Inc. (115889214)

Registrant - Addison Biological Laboratory, Inc. (832629203)

Establishment
Name	Address	ID/FEI	Business Operations
Addison Biological Laboratory, Inc.		832629203	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