PRODINE SOLUTION- povidone iodine solution 
PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.

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.

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Prodine Solution

Povidone-Iodine Solution
(Titratable Iodine 1.0%)

Non-Irritating, Non-Staining Antiseptic Microbicide

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.

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ACTIVE INGREDIENT:

Povidone Iodine (1.0% Titratable).

INACTIVE INGREDIENTS:

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

AVOID STORING AT EXCESSIVE HEAT.

Net Contents

One Gallon (3.785 liters)

Trademarks are property of Clipper Distributing Company, LLC

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

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One Gallon (3.785 liters)

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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

Revised: 1/2018
Document Id: dde481dd-d010-46ee-a41e-ee2bd0a498d8
Set id: 59f02fd6-6534-425b-896d-a227be84a75d
Version: 2
Effective Time: 20180123
 
PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC.