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, 7.5%

(equivalent to 0.75% available iodine)

Purpose

Antiseptic

Uses

• For preparation of the skin prior to surgery
• helps to reduce bacteria that potentially can cause skin infection
• significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only.

Do not use

• in the eyes
• if you are allergic to iodine or any of the other ingredients in the product.

When using this product

• prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
• in pre-operative prepping, avoid “pooling” beneath the patient.

Stop use and ask a doctor

• if irritation and redness develop
• if condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

Surgical Hand Scrub:

• Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge.
• Wet hands and forearms
• Apply 5 milliliters (teaspoonful) or palmful to hands and forearms
• Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces
• Use a sterile scrub brush, if desired
• Rinse and repeat scrub

Patient Pre-operative Skin Preparation:

• Prior to surgery, wet skin with water
• Apply scrub to the operative site
• scrub thoroughly for about 5 minutes
• Rinse using sterile gauze or towel, or remove with 70 percent alcohol
• follow with application of Medline Prep Solution and allow to dry

Other Information

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

Inactive Ingredients

Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, Water

Manufacturing Information

www.medline.com

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

Made in Mexico To Order Call: 1-800-MEDLINE RK16DEG

Package Label

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-944
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
MONOETHANOLAMINE (UNII: 5KV86114PT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-944-04	118 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)

Establishment
Name	Address	ID/FEI	Business Operations
Degasa, S.A. de C.V.		812771980	manufacture(53329-944)