Label: POVIDONE-IODINE solution
- NDC Code(s): 13985-929-01
- Packager: MWI/VETONE
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated July 24, 2023
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- Ingredients
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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.
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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.
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INGREDIENTS AND APPEARANCE
POVIDONE-IODINE
povidone-iodine solutionProduct 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
