ANGELS EYES- zinc otic solution

ANGELS EYES by

Drug Labeling and Warnings

ANGELS EYES 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]

SPL UNCLASSIFIED SECTION

ANGELS' EYES®

ZINC-OTIC

Ear Care

Ear Relief Treatment

Natural Boric Acid and Zinc Formula

Helps Calm Itchy and Inflamed Ears

1 FL OZ (29.5 mL)

SPL UNCLASSIFIED SECTION

Angels' Eyes ZINC OTIC is a non-staining ear care formula for pets that helps eliminate odor-causing bacteria and yeast while nourishing and replenishing the ear epithelium. Helps treat canine Chronic Yeast Otitis.

DIRECTIONS:

Cleanse ear canal with suitable cleanser. Fill cleansed ear canal with Zinc-Otic, 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.

Safe for long term maintenance.

INGREDIENTS:

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

WARNINGS

KEEP OUT OF REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

MADE IN USA.

DISTRIBUTED BY:

H&C Animal Health

Parker, CO 80134

www.AngelEyesOnline.com

Questions or comments?

1-855-726-1856

Rev. 0

Package label, display panel

ANGELS' EYES®

ZINC-OTIC

Ear Care

Ear Relief Treatment

Natural Boric Acid and Zinc Formula

Helps Calm Itchy and Inflamed Ears

1 FL OZ (29.5 mL)

Angels' Eyes ZINC OTIC is a non-staining ear care formula for pets that helps eliminate odor-causing bacteria and yeast while nourishing and replenishing the ear epithelium. Helps treat canine Chronic Yeast Otitis.

DIRECTIONS:

Cleanse ear canal with suitable cleanser. Fill cleansed ear canal with Zinc-Otic, 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.

Safe for long term maintenance.

INGREDIENTS:

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

KEEP OUT OF REACH OF CHILDREN.

MADE IN USA.

DISTRIBUTED BY:

H&C Animal Health

Parker, CO 80134

www.AngelEyesOnline.com

Questions or comments?

1-855-726-1856

Rev. 0

INGREDIENTS AND APPEARANCE

ANGELS EYES 
zinc otic solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86137-7509
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: 86137-7509-2	29.5 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