Label: PRAMOX- pramoxine hydrochloride shampoo

  • NDC Code(s): 68898-124-16
  • 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

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

  • ​Drug Facts

  • ​Active Ingredients

    Pramoxine Hydrochloride , USP 1%

  • ​Purpose

    Topical Anesthetic

  • ​Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Disodium Cocoamphodiacetate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Hydrolyzed Oats, Carthamus tinctorius (Safflower) Seed Oil, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone.

  • ​Uses:

    a medicated shampoo 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. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

  • ​Precautions

    For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult a veterinarian. Avoid contact with the 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 Shampoo

    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

    To learn more about our products, visit:

    ​www.anmpharm.com

    ​SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

    ​MANUFACTURED FOR
    Animal Pharmaceuticals

    MADE IN THE USA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    PRAMOX 
    pramoxine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-124
    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)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    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:68898-124-16474 mL in 1 BOTTLE, PLASTIC
    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)