Label: GNC PET WELLNESS ULTRA MEDICATED HOT SPOT- pramoxine hydrochloride spray

  • NDC Code(s): 43655-856-12
  • Packager: General Nutrition Corporation
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated May 1, 2020

If you are a consumer or patient please visit this version.

  • 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

    IMAGE

  • INGREDIENTS AND APPEARANCE
    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)