Label: PRAMOX- pramoxine hydrochloride spray

  • NDC Code(s): 68898-125-08
  • Packager: Animal Pharmaceuticals
  • 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 October 18, 2021

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  • Drug Facts

  • Active Ingredients

    Parmoxine Hydrochloride, USP 1%

  • Purpose

    Topical Anesthetic

  • Inactive Ingredients

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

  • Uses:

    a medicated spray for the temporary relief of itching and scratching on dogs, cats and horses with dermatological conditions responsive to pramoxine.

  • Directions for Use:

    Shake well before use. Spray directly onto affected skin area(s). If necessary, ruffle or part the hair to allow direct contact with the skin. Rub in well. May be used daily or as directed by veterinarian.

  • Precautions

    For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult a veterinarian. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

  • SPL UNCLASSIFIED SECTION

    Anti-itch Spray 

    For Temporary Relief Of Dermatological Conditions Responsive To Pramoxine.

    Tropical Guava

    Formulated for Dogs, Cats & Horses

    At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond....and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your veterinarian.

    OUR ASSURANCE
    Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

    Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

    ALL PRODUCTS ARE MADE IN THE U.S.A. AND 100% QUALITY GUARANTEED.

    To learn more about our products, visit:

    www.anmpharm.com

    SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

    MANUFACTURED FOR
    Animal Pharmaceuticals

    MADE IN THE USA

  • PRINCIPAL DISPLAY PANEL

    Packagingspray

  • INGREDIENTS AND APPEARANCE
    PRAMOX 
    pramoxine hydrochloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON (UNII: Z4152N8IUI)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)  
    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:68898-125-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/15/2021
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Stratford Care Usa, Inc. (036650469)
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

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Clinical Trials, PubMed, Biochemical Data Summary

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