PLAQCLNZ- zinc gluconate gel

PlaqClnz by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOSAGE & ADMINISTRATION

DIRECTIONS: Apply Gel directly on the gums outside the back upper molars once a day. One drop placed on each side of the mouth in adult cats. Use slightly more for small dogs. Use 3 to 5 drops on medium to large dogs using direct application tip. A natural cleansing action will distribute the gel to remote areas of the mouth. Use daily for best results.

DESCRIPTION

INGREDIENTS: Deionized Water, Carboxymethylcellulose, 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 #24833

SmartPractice

Manufactured for SmartPractice®
Phoenix, AZ 85008 Made in USA

PRINCIPAL DISPLAY PANEL

PlaqClnz®
Gel

Fresh Breath. Healthy Mouth. Happier Pet.

Natural 1-Step Oral Cleansing
Without Brushing
Taste-free

2 FL. OZ. (59ml)

DIRECTIONS: Apply Gel directly on the gums outside the back upper molars once a day. One drop placed on each side of the mouth in adult cats. Use slightly more for small dogs. Use 3 to 5 drops on medium to large dogs using direct application tip. A natural cleansing action will distribute the gel to remote areas of the mouth. Use daily for best results.

INGREDIENTS: Deionized Water, Carboxymethylcellulose, 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 #24833

SmartPractice

Manufactured for SmartPractice®
Phoenix, AZ 85008 Made in USA

INGREDIENTS AND APPEARANCE

PLAQCLNZ 
zinc gluconate gel

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 69521-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Gluconate	0.0165 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
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: 69521-002-03	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 - SmartHeatlh, 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
ADAMSON ANALYTICAL LABORATORIES INC		944399906	analysis

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

Establishment
Name	Address	ID/FEI	Business Operations
Jost Chemical Co.		147882294	api manufacture