GNC PET WELLNESS ULTRA MEDICATED HOT SPOT- pramoxine hydrochloride spray 
General Nutrition Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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GNC PET WELLNESS ULTRA MEDICATED HOT SPOT SPRAY

Active Ingredients:

Pramoxine Hydrochloride 1.0%

ANTI-ITCH

Keep out of reach of children and animals

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.

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

Store in a cool, dry place.

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

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

IMAGE

GNC PET WELLNESS ULTRA MEDICATED HOT SPOT 
pramoxine hydrochloride spray
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-856
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43655-856-12354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/27/2020
Labeler - General Nutrition Corporation (014960165)

Revised: 5/2020
Document Id: 19adbed6-3a31-4923-ae9f-266e0d99d1d9
Set id: 767e0f44-2e44-4f55-aeab-08d4bba75ab2
Version: 1
Effective Time: 20200501
 
General Nutrition Corporation