GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF CONDITIONER- pramoxine hydrochloride shampoo

GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF CONDITIONER by

Drug Labeling and Warnings

GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF CONDITIONER by is a Animal medication manufactured, distributed, or labeled by General Nutrition Corporation, Syn-Tech Chem. & Pharm. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Pramoxine Hydrochloride 1.0%

PURPOSE

ANTI-ITCH

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets.

DOSAGE & ADMINISTRATION

Directions: 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 thoroughly and towel dry.

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

PRECAUTIONS

Cautions: 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 veterinarian.

Do not use more frequently than once a week. Do not use on broken or inflamed skin.

Do not use on cats.

INACTIVE INGREDIENT

Inactive Ingredients(99.9%): Water, Cetearyl Alcohol, PEG-40 Hydrogenated Castor Oil, Stearalkonium Chloride, Glycerin, Dimethicone, Fragrance, Polysorbate-60, Hydrolyzed Oats, Hydrolyzed Wheat Protein, Methylchloroisothiazolinone, Methylisothiazolinone

QUESTIONS OR COMMENTS?

VISIT: GNC.COM / CALL: 877-462-4700

SPL UNCLASSIFIED SECTION

for adult dogs

Relieves itching, scratching, and redness

No artificial colors

THIS FORMULA CONTAINS

• Pramoxine Hydrochloride, which has been shown to have analgesic effects.
• Formulated with Hydrolysed Oats which can be soothing to the skin. 

GNC medicated pet grooming products are designed to go above and beyond the everyday shampoo.

Enriched with high-quality ingredients, GNC formulas are pH balanced and will leave your pet smelling incredibly fresh, while helping

to relieve discomfort associated with irritating skin conditions.

GNC PETS QUALITY COMMITMENT

Since 1935, GNC has been the leader in the development and manufacture of human nutritional supplements. GNC's commitment

carries over to Pet Products! GNC Pet Products are produced at the highest-quality standards as our human products.

Distributed by:

Fetch for Pets, New York, NY 10018

MADE IN U.S.A. with globally sourced ingredients.

GNC Pets and the GNC Pets logo are registered trademarks of General Nutrition Centers, Inc. and are used under licence by Fetch for Pets.

All rights reserved.

Packaging

INGREDIENTS AND APPEARANCE

GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF CONDITIONER 
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 43655-854
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 60 (UNII: CAL22UVI4M)
OAT (UNII: Z6J799EAJK)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43655-854-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/27/2020

Labeler - General Nutrition Corporation (014960165)

Establishment
Name	Address	ID/FEI	Business Operations
Syn-Tech Chem. & Pharm. Co., Ltd.		656002532	api manufacture