GNC PETS ITCH RELIEF (PREMIUM FORMULA)- pramoxine hydrochloride, hydrocortisone, and lidocaine hydrochloride shampoo

GNC Pets Itch Relief (Premium Formula) by

Drug Labeling and Warnings

GNC Pets Itch Relief (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

342000
IMG

INDICATIONS & USAGE

Directions for use:

Using warm water, wet coat thoroughly. Apply shampoo from base of neck to the tail, paying special attention to avoid eyes. Gently massage deep into coat and skin. Allow shampoo to remain on pet for up to 5 minutes for maximum benefit. Rinse well. Repeat as needed.

SPL UNCLASSIFIED SECTION

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

Keep out of reach of children and pets. Do not use more frequently than once a week.

For maximum relief, follow with GNC Pets Itch Relief Medicated Conditioner to speed the relief of symptoms.

SPL UNCLASSIFIED SECTION

• Pramoxine HCL: 0.25%
• Hydrocortisone: 0.05%
• Lidocaine HCL: 0.05%

SPL UNCLASSIFIED SECTION

Other Ingredients: Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Sodium Lactate, Glycerin, Retinyl Palmitate, Panthenol, Aloe Barbadensis Leaf Juice, Pramoxine HCL, Styrene/Acrylates Copolymer, Hydrocortisone, Lidocaine HCL, Fragrance, DMDM Hydantoin, Caramel, Blue 1.

SPL UNCLASSIFIED SECTION

For more information: 1-888-612-1198

SHOP NOW @ PETSMART.COM

Distributed by:
General Nutrition Corporation
Pittsburgh, PA 15222

PRINCIPAL DISPLAY PANEL - 503 ML Bottle Label

MEDICATED+
ITCH RELIEF
SHAMPOO

PREMIUM FORMULA

GNC
PETS

S
MEDICATED
SHAMPOO

Relieves itching, scratching
and redness

With hydrocortisone to
calm irritated skin

MEDICATED CARE
+
MEDICATED CARE

EUCALYPTUS SCENT
NET WT. 17 OZ (503 ML)

INGREDIENTS AND APPEARANCE

GNC PETS ITCH RELIEF (PREMIUM FORMULA) 
pramoxine hydrochloride, hydrocortisone, and lidocaine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 43655-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	2.5 mg  in 1 mL
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	0.5 mg  in 1 mL
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Decyl Glucoside (UNII: Z17H97EA6Y)
Sodium Lactate (UNII: TU7HW0W0QT)
Glycerin (UNII: PDC6A3C0OX)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Panthenol (UNII: WV9CM0O67Z)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
DMDM Hydantoin (UNII: BYR0546TOW)
Caramel (UNII: T9D99G2B1R)
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: 43655-000-01	503 mL in 1 BOTTLE, PLASTIC
2	NDC: 43655-000-02	946 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