Label: HYDROCORTISONE- hydrocortisone, pramoxine hydrochloride spray

  • NDC Code(s): 68898-127-04, 68898-127-08
  • 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 November 5, 2021

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  • Drug Facts

  • Active Ingredients

    Hydrocortisone, USP ............................... 1% 
    Pramoxine Hydrochloride, USP ............ 0.5% 

  • Purpose

    Anti-Inflammatory
    Topical Anesthetic

  • Inactive Ingredients

    Propylene Glycol, Water, SD Alcohol 40B, Glycerin, PEG-75 Lanolin, Hydrolyzed Oats, Benzyl Alcohol.

  • Uses

    helps to relieve symptoms of hot spots, bites and skin conditions so your pet can heal quickly.

  • 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.

  • Directions for Use

    Spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion.

  • Precautions

    Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

  • Cautions

    If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

  • SPL UNCLASSIFIED SECTION

    For Relief Of Skin Conditions Associated With Hot Spots, Allergies, And Dermatitis

    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 Pharmaceutical 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 help 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

    AX0090
    REV 0921
    AX0091
    REV 1021

    MADE IN THE USA

  • Packaging

    Spray

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone, pramoxine hydrochloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    OAT (UNII: Z6J799EAJK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-127-04118 mL in 1 BOTTLE, SPRAY
    2NDC:68898-127-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/04/2021
    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)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

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