Label: COMFORT HC- hydrocortisone and pramoxine spray

  • NDC Code(s): 68898-110-04
  • Packager: Animal Pharmaceuticals
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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Drug Label Information

Updated November 11, 2021

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose

    Pramoxine HCl ……... 1% (w/w)  ………Topical Anesthetic

    Hydrocortisone.......... 1% (w/w)  ………Anti-Inflammatory

  • PURPOSE


    Uses a medicated spray for the temporary relief of itching and scratching on dogs, cats and horses. For localized treatment between generalized therapy.

  • WARNINGS AND PRECAUTIONS

    Warnings

    • For Animal Use Only
    • Consult your veterinarian before use

    Caution: ▪ Do not use in the eyes or nose. ▪ Not for prolonged use. ▪ If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by your veterinarian.

    Ask a veterinarian before use if your animal is using other medications.

    When Using this Product

    • use only on dogs, cats and horses
    • use topically only
    • avoid contact with eyes and mucous membranes

    Keep out of reach of children. In case of contact with eyes or mucous membranes, rinse thoroughly with water. If irritation develops or increases, discontinue use and consult your veterinarian.

  • DOSAGE & ADMINISTRATION

    Directions for Use

    Treat affected areas 2-3 times daily, or as directed by your veterinarian. Do not allow animal to lick the treated area until dry to prevent ingestion.

  • PRINCIPAL DISPLAY PANEL

    ComHC0812

  • INGREDIENTS AND APPEARANCE
    COMFORT HC 
    hydrocortisone and pramoxine spray
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:68898-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE9.35 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE9.35 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-110-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2010
    Labeler - Animal Pharmaceuticals (166472444)
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