CUTISCLR7.0- zinc gluconate spray

CutisClr7.0 by

Drug Labeling and Warnings

CutisClr7.0 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: Thoroughly clean skin and dry the affected area, then spray site. Apply once or twice daily. Affected areas may be bandaged or exposed.

SPL UNCLASSIFIED SECTION

BENEFITS: A protective counterirritant topical to aid in the management of superficial wounds, abrasions or raw skin of dogs or cats. A natural neutralized zinc solutions that provides relief. Can be used as an adjunct to standard antibiotic or steroid therapy.

PRECAUTIONS

PRECAUTIONS: If no improvement is observed within seven days of treatment, consult your veterinarian.

DESCRIPTION

INGREDIENTS: Deionized Water, Glycerin, Zinc Gluconate, L-lysine, Taurine, Carboxymethylcellulose, Methylparaben, Propylparaben.

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

Item #24835

SmartPractice®

Manufactured for SmartPractice®
Phoenix, AZ 85008 Made in USA 75384_0309

PRINCIPAL DISPLAY PANEL

CutisClr 7.0™

for Dogs

Quick Results. Healthier Skin. Happier Pet.

Relieves Itching
Relieves Dry Skin
Helps Promote Healing

2 FL. OZ. (59ml)

DIRECTIONS: Thoroughly clean skin and dry the affected area, then spray site. Apply once or twice daily. Affected areas may be bandaged or exposed.

BENEFITS: A protective counterirritant topical to aid in the management of superficial wounds, abrasions or raw skin of dogs or cats. A natural neutralized zinc solutions that provides relief. Can be used as an adjunct to standard antibiotic or steroid therapy.

PRECAUTIONS: If no improvement is observed within seven days of treatment, consult your veterinarian.

INGREDIENTS: Deionized Water, Glycerin, Zinc Gluconate, L-lysine, Taurine, Carboxymethylcellulose, Methylparaben, Propylparaben.

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

Item #24835

SmartPractice®

Manufactured for SmartPractice®
Phoenix, AZ 85008 Made in USA

75384_0309

INGREDIENTS AND APPEARANCE

CUTISCLR7.0 
zinc gluconate spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 69521-004
Route of Administration	TOPICAL

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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LYSINE (UNII: K3Z4F929H6)
TAURINE (UNII: 1EQV5MLY3D)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-004-01	59 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/27/2010

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