Label: PRODINE SOLUTION- povidone iodine solution

  • NDC Code(s): 57319-328-09
  • Packager: PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 23, 2018

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  • Povidone-Iodine Solution(Titratable Iodine 1.0%)

    Non-Irritating, Non-Staining Antiseptic Microbicide

  • KEEP OUT OF REACH OF CHILDREN

    FOR ANIMAL USE ONLY

    FOR EXTERNAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS:

    Kills gram-negative and grampositive bacteria, fungi, viruses, protozoa, and yeasts. Film-forming, virtually non-irritating and non-staining to skin, hair and natural fabrics.

  • DIRECTIONS:

    Apply full-strength as often as needed. Wet area thoroughly to insure complete coverage and penetration but avoid “pooling”. May be covered with bandage if necessary.

  • CAUTION:

    Avoid contact with eyes. May be harmful if swallowed. If redness, swelling or irritation occurs discontinue use and consult a veterinarian. Do not use on animals that are allergic or sensitive to iodine. In case of deep or puncture wounds or serious burns, consult a veterinarian.

    image of eye clock

  • ACTIVE INGREDIENT:

    Povidone Iodine (1.0% Titratable).

  • INACTIVE INGREDIENTS:

    Purified Water, Sodium Phosphate Dibasic, Glycerin, Ethoxylated Alcohol, Citric Acid.

  • STORAGE AND HANDLING

    AVOID STORING AT EXCESSIVE HEAT.

  • Net Contents

    One Gallon (3.785 liters)

  • INFORMATION FOR OWNERS/CAREGIVERS

    Trademarks are property of Clipper Distributing Company, LLC

    Manufactured by:
    First Priority, Inc.
    Elgin, IL U.S.A.

    image of clipper logo

  • One Gallon (3.785 liters)

    image of LBPHPI050_r0315

  • INGREDIENTS AND APPEARANCE
    PRODINE  SOLUTION
    povidone iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-328
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE65.9 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-328-094 in 1 CASE
    13.785 L in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/22/2018
    Labeler - PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC. (150711039)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture, label
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