Label: GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF- pramoxine hydrochloride shampoo

  • NDC Code(s): 43655-849-16
  • 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 April 28, 2020

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

  • 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

    IMAGE

  • INGREDIENTS AND APPEARANCE
    GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF 
    pramoxine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-849
    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)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-849-16473 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)