Animal NDC 86045-5000-3 Zn4.5otic

Zinc Gluconate

Animal Product Information

Field Name Field Value
Animal NDC Code 86045-5000-3
Proprietary Name Zn4.5otic What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Zinc Gluconate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Addison Biological Laboratory, Inc.
Product Type Otc Animal Drug
Usage Information
    INDICATIONS:A natural, complexed zinc, non-staining ear care formula for pets.  Helps eliminate odor-causing bacteria.  Nourishes and replenishes the ear epithelium.  
Active Ingredient(s)
  • Zinc Gluconate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • TAURINE (1EQV5MLY3D)
  • METHYLPARABEN (A2I8C7HI9T)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • LYSINE (K3Z4F929H6)
  • BORIC ACID (R57ZHV85D4)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • TAURINE (1EQV5MLY3D)
  • METHYLPARABEN (A2I8C7HI9T)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • LYSINE (K3Z4F929H6)
  • BORIC ACID (R57ZHV85D4)
  • PROPYLENE GLYCOL (6DC9Q167V3)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Zn4.5otic Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.  


Other



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. 05/13


Package Label.Principal Display Panel



MAXI/GUARD®
Zn4.5Otic®
A Natural
Ear Care Solution
Delivering
Complexed Zinc™
1 FL. OZ. (29.5mL)
INDICATIONS:
A natural, complexed zinc,
non-staining ear care formula
for pets. Helps eliminateodor-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. 06/19

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. 01/21

MAXI/GUARD®
Zn4.5Otic®
A Natural
Ear Care Solution
Delivering
Complexed Zinc™
4 FL. OZ. 118mL)
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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.