Label: HYDROCORTISONE- hydrocortisone, pramoxine hydrochloride spray

  • NDC Code(s): 86069-120-04, 86069-120-08
  • Packager: Stratford Care Usa, Inc.
  • Category: OTC ANIMAL DRUG LABEL

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Drug Label Information

Updated November 22, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Hydrocortisone 1%,
    Pramoxine Hydrochloride 0.5%

  • PURPOSE

    ANTIPRURITIC

  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    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

    Cautions: For animal use only. For external use only. 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. Keep out of the reach of children.

  • STORAGE AND HANDLING

    Storage: Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    MEDICATED SPRAY

    RELIEVES SYMPTOMS OF HOT SPOTS, BITES & SKIN CONDITIONS

    FOR DOGS, CATS & HORSES

    Stratford Animal Care
    A MEMBER OF THE SWEDENCARE FAMILY

    Distributed by:
    StratfordCare USA
    Odessa, FL 33556
    877-498-2002
    www.stratfordrx.com

  • Packaging

    Stratford-120

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone, pramoxine hydrochloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-120
    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:86069-120-04118 mL in 1 BOTTLE, SPRAY
    2NDC:86069-120-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/15/2021
    Labeler - Stratford Care Usa, Inc. (036650469)
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