POVIDONE-IODINE solution

Povidone-Iodine by

Drug Labeling and Warnings

Povidone-Iodine by is a Animal medication manufactured, distributed, or labeled by MWI/VETONE, VI-JON, LLC, Thatcher Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Ingredients

ACTIVE INGREDIENT: Povidone-Iodine 7.5% (0.75% available Iodine)

INACTIVE INGREDIENT: alcohol denat., C12-13 pareth-9. citric acid, disodium phosphate, hydroxyethylcellulose, sodium hydroxide, water

Indications and Use

INDICATIONS: A germicidal cleanser for preoperative and postoperative skin washing, and shampoo for bacterial and fungal skin infections in animals. Used routinely, it helps prevent infection in cuts, scratches, abrasions, and burns. Non-staining to skin, hair and natural fabrics after repeated wash.

DIRECTIONS FOR USE: PREOPERATIVE SKIN PREPARATION: After the surgical area is clipped, wet with water. Apply scrub (1 mL is sufficient to cover an area of 20 to 30 square inches), develop lather, and scrub thoroughly for approximately 5 minutes. Rinse using sterile gauze saturated with water. The area may then be painted with Povidone Iodine Scrub and allowed to dry.

Warning

For external use only. Do not use this product in the eyes or on food-producing animals.

When using this product, prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions. In preoperative prepping, avoid “pooling” beneath the animal. Stop use and ask a veterinarian if irritation and redness develops or in rare instances of local irritation or sensitivity. If swallowed, get medical help or contact a Poison Control Center right away.

Storage

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

Adverse event

TAKE TIME OBSERVE LABEL DIRECTIONS

Distributed by: MWI, Boise, ID 83705

www.VetOne.net

Principal Panel Display

NDC: 13985-929-01

VETONE

Pivodine Scrub

(Povidone Iodine 7.5%)

Antiseptic

Microbicide Solution

Pre-operative Skin Cleanser

FOR ANIMAL USE ONLY

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

128 FL OZ (1 GAL) 3.79 L

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-929
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
C12-13 PARETH-9 (UNII: 9BXD858P37)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-929-01	3790 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/14/2018

Labeler - MWI/VETONE (019926120)

Registrant - VI-JON, LLC (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
VI-JON, LLC		790752542	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
VI-JON, LLC		088520668	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Thatcher Company		041307356	api manufacture