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

GNC Pets Itch Relief Conditioner (Premium Formula) by

Drug Labeling and Warnings

GNC Pets Itch Relief Conditioner (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

342003
IMG

DOSAGE & ADMINISTRATION

Directions for use:

Apply conditioner liberally from base of neck to the tail, paying special attention to avoid eyes. Work thoroughly through the coat. Allow conditioner to remain on pet for up to 5 minutes for maximum benefit. Rinse well and towel dry.

SAFE HANDLING WARNING

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, use with GNC Pets Itch Relief Medicated Shampoo to speed the relief of symptoms.

DESCRIPTION

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

Other Ingredients: Water, Cetearyl Alcohol, Glycerin, Cetyltrimethylammonium Chloride, Dimethicone, Retinyl Palmitate, Panthenol, Aloe Barbadensis Leaf Juice, Pramoxine HCL, Polyquaternium-10, Disodium EDTA, Hydrocortisone, Lidocaine HCL, Fragrance, DMDM Hydantoin, 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
CONDITIONER

PREMIUM FORMULA

GNC
PETS

C
MEDICATED
CONDITIONER

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 CONDITIONER (PREMIUM FORMULA) 
pramoxine hydrochloride, hydrocortisone, and lidocaine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 43655-003
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)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glycerin (UNII: PDC6A3C0OX)
Cetrimonium Chloride (UNII: UC9PE95IBP)
Dimethicone (UNII: 92RU3N3Y1O)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Panthenol (UNII: WV9CM0O67Z)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Polyquaternium-10 (400 MPA.S at 2%) (UNII: HB1401PQFS)
Edetate Disodium (UNII: 7FLD91C86K)
DMDM Hydantoin (UNII: BYR0546TOW)
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: 43655-003-02	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