Label: EQUISHIELD IR- pramoxine hydrochloride, hydrocortisone shampoo

  • NDC Code(s): 51031-016-12
  • Packager: Kinetic Technologies, LLC
  • 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 March 2, 2021

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  • Drug Facts:Active Ingredients:

    Pramoxine Hydrochloride........... 1% (w/w)

    Hydrocortisone......................... 1% (w/w)

    Purpose

    .........Topical Anesthetic

    .........Anti-inflammatory

  • Uses:

    EquiShield IR (Itch Relief) Shampoo is a soothing anti-inflammatory formulation that contains Pramoxine and micronized colloidal oatmeal, combined with Hydrocortisone for the temporary relief of itching, flaking and inflammation. The EquiShield IR Shampoo formulation starts with a moistening base for a long-lasting soothing effect. Added coat conditioners and Omega-6 Essential Fatty Acids nourish the skin and help control irritation. For use on horses, dogs and cats.

  • Cautions:

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

  • Directions:

    Wet coat thoroughly with water. Apply and lather EquiShield​ IR Shampoo over the affected skin area(s), allowing 5 to 10 minutes of contact time. Rinse completely with clean water. Repeat if necessary or as directed by your veterinarian.

  • Other Information:

    • Store at room temperature 15° - 30º C (58° - 86°F).
    • Store in a cool, dry place.
  • SPL UNCLASSIFIED SECTION

    Made in U.S.A.

    #9008-09-00

    KINETIC™

    P.O. Box 12388, Lexington, KY 40583

    877.786.9882 • Fax: 859.258.9177

    www.KineticVet.com

  • KINETIC™VET

    EquiShield®

    IR

    Shampoo

    Pramoxine 1%

    Hydrocortisone 1%

    with Colloidal Oatmeal

    Itch Relief Shampoo

    FOR VETERINARY USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    Net Contents: 12 fl oz (355 ml)

    image description

  • INGREDIENTS AND APPEARANCE
    EQUISHIELD IR 
    pramoxine hydrochloride, hydrocortisone shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51031-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51031-016-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/14/2015
    Labeler - Kinetic Technologies, LLC (164935731)