GNC PETS HOT SPOT (PREMIUM FORMULA)- diphenhydramine hydrochloride, hydrocortisone, and benzethonium chloride spray

GNC Pets Hot Spot (Premium Formula) by

Drug Labeling and Warnings

GNC Pets Hot Spot (Premium Formula) by is a Animal medication manufactured, distributed, or labeled by General Nutrition Corporation, Marianna Industries, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

342002
FNG

Directions for Use:

Hold bottle 8 to 10 inches from coat and spray onto affected area.

SAFE HANDLING WARNING

For external use only. Safe for dogs 12 weeks of age and older. Avoid contact with eyes. In case of eye contact, flush thoroughly with water. If condition persists more than 7 days, consult your veterinarian.

SPL UNCLASSIFIED SECTION

Keep out of reach of children and pets.

DESCRIPTION

• Diphenhydramine Hydrochloride: 0.50%
• Hydrocortisone: 0.05%
• Benzethonium Chloride: 0.05%

Other Ingredients: Water, Alcohol, Glycerin, Sucrose, Polysorbate 20, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Thiamine Hydrochloride, Cyanocobalamin, DMDM Hydantoin.

For More Information:

1-888-612-1198

SHOP NOW @ PETSMART.COM

Distributed by:
General Nutrition Corporation
Pittsburgh, PA 15222

PRINCIPAL DISPLAY PANEL - 300 mL Bottle Label

MEDICATED +
HOT SPOT
SPRAY

GNC
PETS

PREMIUM FORMULA

S
MEDICATED
SPRAY

Relieves discomfort
associated with hot spots

Helps reduce itching,
swelling and redness

Contains ingredients to
help reduce infection

MEDICATED CARE
+
MEDICATED CARE

UNSCENTED
Net Wt. 10.14 fl oz
(300 mL)

INGREDIENTS AND APPEARANCE

GNC PETS HOT SPOT (PREMIUM FORMULA) 
diphenhydramine hydrochloride, hydrocortisone, and benzethonium chloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 43655-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	5 mg  in 1 mL
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	0.5 mg  in 1 mL
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP)	Benzethonium Chloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Glycerin (UNII: PDC6A3C0OX)
Sucrose (UNII: C151H8M554)
Polysorbate 20 (UNII: 7T1F30V5YH)
Panthenol (UNII: WV9CM0O67Z)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Thiamine Hydrochloride (UNII: M572600E5P)
Cyanocobalamin (UNII: P6YC3EG204)
DMDM Hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43655-002-01	503 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		04/30/2012

Labeler - General Nutrition Corporation (014960165)

Establishment
Name	Address	ID/FEI	Business Operations
Marianna Industries, Inc		045570736	MANUFACTURE, API MANUFACTURE