POVIDONE-IODINE solution

Povidone-Iodine by

Drug Labeling and Warnings

Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-Iodine, 10%

(equivalent to 1% available iodine)

Purpose

Antiseptic

Uses

■ Healthcare antiseptic for preparation of the skin prior to surgery

■ First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do not use

■ in the eyes

■ longer than 1 week unless directed by a doctor

■ on individuals who are allergic or sensitive to iodine

■ or apply over large areas of the body

Stop use and ask a doctor

• if irritation and redness develop
• if condition persists for more than 72 hours
• in case of deep or puncture wounds, animal bites or serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Clean the affected area

• For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
• For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Nonylphenol 9, Purified Water, Sodium Citrate

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured for: Medline Industries Inc., Three Lakes Drive, Northfield, IL 60093 USA

Made in Mexico To Order Call: 1-800-MEDLINE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-943
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
N-NONYLPHENOL (MIXED ISOMERS) (UNII: 79F6A2ILP5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-943-69	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2016
2	NDC: 53329-943-13	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/04/2016

Labeler - Medline Industries, Inc. (025460908)