GNC PET WELLNESS ULTRA MEDICATED HOT SPOT- pramoxine hydrochloride spray

GNC PET WELLNESS ULTRA MEDICATED HOT SPOT by

Drug Labeling and Warnings

GNC PET WELLNESS ULTRA MEDICATED HOT SPOT 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

ANTI-ITCH

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and animals

DOSAGE & ADMINISTRATION

Directions: Hold bottle 8-10 inches from coat and spray onto affected area. If condition persists more than 7 days, consult your veterinarian. For use on dogs 8 weeks of age and older only.

PRECAUTIONS

Cautions: Do not use on broken or inflamed skin. For use on dogs only. Do not allow pet to ingest. For animal use only.

STORAGE AND HANDLING

Store in a cool, dry place.

INACTIVE INGREDIENT

Inactive Ingredients (99.0%): Water, Glycerin, Stearamidopropyl Dimethylamine Lactate, Silicone Emulsion, Polysorbate 20, Carthamus Tinctorius (Safflower) Seed Oil, Sodium Lactate, Fragrance, PEG-75 Lanolin, Hydrolyzed Oats, Methylisothiazolinone.

QUESTIONS OR COMMENTS?

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

SPL UNCLASSIFIED SECTION

For adult dogs

Relieves discomfort associated with hot spots
Helps reduce itching and irritation
Alcohol-free

THIS FORMULA CONTAINS

 PEG-75 Lanolin is an excellent skin protectant and moisturizer.
Safflower oil is a natural source of Essential Fatty Acids useful in keeping skin moisturized.

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 source 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 HOT SPOT 
pramoxine hydrochloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 43655-856
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)
GLYCERIN (UNII: PDC6A3C0OX)
STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
1,1'-OXYBIS(2-PROPANOL) (UNII: D5SV08985Z)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SAFFLOWER OIL (UNII: 65UEH262IS)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
OAT (UNII: Z6J799EAJK)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43655-856-12	354 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)