PRODINE SOLUTION- povidone iodine solution

Prodine by

Drug Labeling and Warnings

Prodine by is a Animal medication manufactured, distributed, or labeled by PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC., FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

One Gallon (3.785 liters)

INGREDIENTS AND APPEARANCE

PRODINE  SOLUTION
povidone iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57319-328
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	65.9 g  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57319-328-09	4 in 1 CASE
1		3.785 L in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/22/2018

Labeler - PHOENIX PHARMACEUTICAL INC./ CLIPPER DISTRIBUTING, INC. (150711039)

Establishment
Name	Address	ID/FEI	Business Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture, label