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

  • NDC Code(s): 43655-854-16
  • 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 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 pets.

  • DOSAGE & ADMINISTRATION

    Directions: Apply conditioner liberally from base of neck to the tail, paying special attention to avoid eyes. Work thoroughly through the coat. Allow conditioner to remain on pet for up to 5 minutes for maximum benefit. Rinse thoroughly and towel dry.

    For maximum relief, follow with GNC Pets® Itch Relief Medicated Shampoo 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(99.9%): Water, Cetearyl Alcohol, PEG-40 Hydrogenated Castor Oil, Stearalkonium Chloride, Glycerin, Dimethicone, Fragrance, Polysorbate-60, Hydrolyzed Oats, Hydrolyzed Wheat Protein, 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

    • Pramoxine Hydrochloride, which has been shown to have analgesic effects.
    • Formulated with Hydrolysed 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 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 licence by Fetch for Pets.

    All rights reserved.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    GNC PET WELLNESS ULTRA MEDICATED ITCH RELIEF CONDITIONER 
    pramoxine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-854
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    OAT (UNII: Z6J799EAJK)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-854-16473 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Syn-Tech Chem. & Pharm. Co., Ltd.656002532api manufacture