Label: NITROFURAZONE SOLUBLE DRESSING- nitrofurazone ointment

  • NDC Code(s): 58829-292-16
  • Packager: FIRST PRIORITY INCORPORATED
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • INDICATIONS:

    For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers.

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  • ADMINISTRATION:

    Apply directly on the lesion with a spatula, or first place on a piece of gauze. Application of a bandage is optional.
    This preparation should be in contact with the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period.

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  • PRECAUTION:

    In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use, reconsult veterinarian. Avoid exposure to alkaline material and fluorescent lighting.

    KEEP AWAY FROM EXCESSIVE HEAT OR DIRECT SUNLIGHT.
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  • CONTENTS:

    0.2% Nitrofurazone in a Water-soluble base of Polyethylene Glycols.

    Do not use in horses intended for human consumption.

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  • HUMAN WARNINGS:

    CARCINOGENESIS: NITROFURAZONE, THE ACTIVE INGREDIENT OF NITROFURAZONE SOLUBLE DRESSING, HAS BEEN SHOWN TO PROOUCE MAMMARY TUMORS IN RATS AND OVARIAN TUMORS IN MICE.
    SOME PEOPLE MAY BE HYPERSENSITIVE TO THIS PRODUCT. EITHER WEAR GLOVES WHEN APPLYING, OR WASH HANDS AFTERWARDS.

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  • STORAGE:

    Store at controlled room temperature between 15°-30°C (59°-86°F).  Keep container tightly closed when not in use.

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  • DISPLAY PANEL

    For Use In Horses Only

    An Antibacterial Preparation for Topical Application

    CAUTION: FEDERAL LAW PROHIBITS THE USE OF THIS PRODUCT IN FOOD-PRODUCING ANIMALS.

    For Animal Use Only

    Keep Out of Reach of Children

    Priority Care is a registered trademark of First Priority, Inc.

    Manufactured By:  FIRST PRIORITY, INC., ELGIN, IL U.S.A

    Made in U.S.A.

    www.prioritycare.com

    Reorder No.TP310PC

    Iss.04-09                         

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  • NET CONTENTS:

    1 lb (453.6 g)

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  • IMAGE OF LABEL

    IMAGE OF LABELIMAGE OF LABEL

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  • INGREDIENTS AND APPEARANCE
    NITROFURAZONE  SOLUBLE DRESSING
    nitrofurazone ointment
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:58829-292
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NITROFURAZONE (NITROFURAZONE) NITROFURAZONE 0.2 g  in 1 g
    Product Characteristics
    Color yellow (YELLOW) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58829-292-16 12 in 1 CASE
    1 453.6 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200425 06/01/2009
    Labeler - FIRST PRIORITY INCORPORATED (179925722)
    Establishment
    Name Address ID/FEI Business Operations
    FIRST PRIORITY INCORPORATED 179925722 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    MINSHENG GROUP SHAOXING PHARMACEUTICAL COMPANY LTD 544607919 api manufacture
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