GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF- pramoxine hydrochloride shampoo

GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF by

Drug Labeling and Warnings

GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF by is a Animal medication manufactured, distributed, or labeled by General Nutrition Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Pramoxine Hydrochloride 1.0%

PURPOSE

HYPO-ALLERGENIC

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets.

DOSAGE & ADMINISTRATION

Directions: 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 thoroughly.

For maximum relief, follow with GNC Ultra Itch Relief Medicated Conditioner 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 (99.0%): Water, Sodium C14-16 Olefin Sulfonate, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Glycerin, Fragrance, Sodium Lactate, Sodium Chloride, Hydrolyzed Oats, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, 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

 Disodium Cocoamphodiacetate is a mild surfactant that helps produce a rich lather.

Formulated with Hydrolyzed 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 same 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 license by Fetch for Pets. All rights reserved.

Packaging

INGREDIENTS AND APPEARANCE

GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF 
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 43655-849
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)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OAT (UNII: Z6J799EAJK)
SAFFLOWER OIL (UNII: 65UEH262IS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43655-849-16	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)