OTICCLRANDCLNZ- zinc gluconate liquid

OticClrandClnz by

Drug Labeling and Warnings

OticClrandClnz by is a Animal medication manufactured, distributed, or labeled by SmartHealth, Inc. (DBA SmartPractice), Addison Biological Laboratory, Inc., Jost Chemical Co., ADAMSON ANALYTICAL LABORATORIES INC, Alliance Analytical Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

INDICATIONS: A natural, complexed zinc, non-staining ear care formula for pets. Helps eliminate odor-causing bacteria. Nourishes and replenishes the ear epithelium.

DOSAGE & ADMINISTRATION

DIRECTIONS: Cleanse ear canal with suitable cleanser. Fill ear canal with OticClr&Clnz™, 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.

SPL UNCLASSIFIED SECTION

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

DESCRIPTION

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

STORAGE AND HANDLING

Store at room temperature. Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Item #24834

SmartPractice®

Manufactured for SmartPractice®

Phoenix, AZ 85008 Made in USA 75261-0309

PRINCIPAL DISPLAY PANEL

Otic
Clr&Clnz™
Quick Results. Healtheir Ears. Happier Pet.

Calms & Clears Problem Ears
A Natural Ear Care Solution
with 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.

DIRECTIONS: Cleanse ear canal with suitable cleanser. Fill ear canal with OticClr&Clnz™, 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 on a regular basis.

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

Store at room temperature. Keep out of reach of children.

Item #24834

SmartPractice®

Manufactured for SmartPractice®

Phoenix, AZ 85008 Made in USA 75261-0309

INGREDIENTS AND APPEARANCE

OTICCLRANDCLNZ 
zinc gluconate liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 69521-003
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	0.011 g  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-003-03	59 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/20/2009

Labeler - SmartHealth, Inc. (DBA SmartPractice) (061081477)

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
ADAMSON ANALYTICAL LABORATORIES INC		944399906	analysis

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