Label: SUFFUSION HC- pramoxine hydrochloride, hydrocortisone spray

  • NDC Code(s): 46066-162-90
  • Packager: Aspen Veterinary Resource, LTD
  • 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 April 27, 2020

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  • DESCRIPTION

    SUFFUSION HC Spray

    ACTIVE INGREDIENTS: Hydrocortisone 1%, Pramoxine Hydrochloride 1%.

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

    PROPERTIES: Suffusion HC spray is a non-stinging formula to help provide relief from itching caused by insect bites, hot spots and other minor skin irritations.  Pramoxine hydrochloride is a mild numbing agent.  Hydrocortisone, lanolin and oatmeal soothe irritated skin.

  • INDICATIONS & USAGE

    INDICATIONS: For the temporary relief of itching and skin irritations in dogs or cats.

    DIRECTIONS FOR USE: Shake well before use.  Apply on dry fur 1-3 times per day for 2-3 weeks or as directed by your veterinarian.  Part the fur and spray directly on the affected area(s) of the skin.  Gently smooth product on to the skin to ensure full coverage.  Do not allow the animal to lick the treated area.

  • WARNINGS AND PRECAUTIONS

    CAUTIONS: For external use on dogs or cats only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.  Wash hands after use.

    WARNING: Keep out of reach of children.

  • STORAGE AND HANDLING

    STORAGE: Store at room temperature. Do not freeze.

  • SPL UNCLASSIFIED SECTION

    QUESTIONS? 1-800-999-0297

    Pivetal

    Distributed by: 

    Aspen Veterinary Resources, LTD

    Liberty, MO 64068

    www.pivetalvet.com

  • PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

    NDC: 46066-162-90

    SUFFUSION 

    HC Spray

    Hydrocortisone 1%

    Pramoxine Hydrochloride 1%

    Soothing Spray 

    with Hydrocortisone 

    FOR CATS OR DOGS

    Wellness by Pivetal

    Net Contents: 8 FL. OZ. (237 mL)

    8 ounce bottle label

  • INGREDIENTS AND APPEARANCE
    SUFFUSION  HC
    pramoxine hydrochloride, hydrocortisone spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-162
    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 (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    OATMEAL (UNII: 8PI54V663Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-162-90237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/27/2020
    Labeler - Aspen Veterinary Resource, LTD (627265361)
    Registrant - Ceva Sante Animale (261126049)
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