PLAQCLNZ- zinc gluconate spray

PlaqClnz by

Drug Labeling and Warnings

PlaqClnz 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]

DOSAGE & ADMINISTRATION

DIRECTIONS: Spray product directly on all teeth and above the outside of the back molars. Recommended amounts: One spray each side of mouth for small dogs. For dogs 20 to 40lbs, increase the amount of sprays to one each side of mouth and front teeth. Dogs 40 lbs or more, spray once each upper and lower jaw area and front teeth.

For best results initiate oral water wash 30 minutes after application. Withhold food and water 30 minutes before and after application.

DESCRIPTION

INGREDIENTS: Deionized Water, Zinc Gluconate, Taurine, Methylparaben, Propylparaben, F. D. & C. Blue #1.

STORAGE AND HANDLING

STORAGE: Store at room temperature and keep out of direct sunlight. Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Item #24831

SmartPractice

Manufactured for SmartPractice®
Phoenix, AZ 85008 Made in USA

PRINCIPAL DISPLAY PANEL

PlaqClnz®
Spray

Fresh Breath. Healthy Mouth. Happier Pet.

Natural 1-Step Oral Cleansing
Without Brushing
Taste-free

2 FL. OZ. (59ml)

DIRECTIONS: Spray product directly on all teeth and above the outside of the back molars. Recommended amounts: One spray each side of mouth for small dogs. For dogs 20 to 40lbs, increase the amount of sprays to one each side of mouth and front teeth. Dogs 40 lbs or more, spray once each upper and lower jaw area and front teeth.

For best results initiate oral water wash 30 minutes after application. Withhold food and water 30 minutes before and after application.

INGREDIENTS: Deionized Water, Zinc Gluconate, Taurine, Methylparaben, Propylparaben, F. D. & C. Blue #1.

STORAGE: Store at room temperature and keep out of direct sunlight. Keep out of reach of children.

Item #24831

SmartPractice

Manufactured for SmartPractice®
Phoenix, AZ 85008 Made in USA

INGREDIENTS AND APPEARANCE

PLAQCLNZ 
zinc gluconate spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 69521-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	0.015 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TAURINE (UNII: 1EQV5MLY3D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-001-01	59 mL in 1 BOTTLE
2	NDC: 69521-001-02	118 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