Label: ZN4.5OTIC- zinc gluconate solution
- NDC Code(s): 86045-5000-1, 86045-5000-2, 86045-5000-3
- Packager: Addison Biological Laboratory, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 2, 2023
If you are a consumer or patient please visit this version.
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- INDICATIONS & USAGE
- INFORMATION FOR OWNERS/CAREGIVERS
- WARNINGS
- INSTRUCTIONS FOR USE
- ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
-
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
-
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. 01/21
-
PRINCIPAL DISPLAY PANEL
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
-
INGREDIENTS AND APPEARANCE
ZN4.5OTIC
zinc gluconate solutionProduct 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. (118396730) 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