POVIDONE-IODINE ANTISEPTIC- povidone-iodine solution
POVIDONE-IODINE- povidone-iodine solution
Medline Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Povidone-Iodine 7.5%

Purpose

Antiseptic

Uses

for preparation of the skin prior to surgery
helps to reduce bacteria that potentially can cause skin infection
for handwashing to reduce bacteria on the skin
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 you have

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 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

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Citric Acid, Cocamide DEA, Disodium Phosphate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

Questions

1-800-MEDLINE

Principal Display Panel

N: 53329-902-13

Scrub Solution

Antiseptic Bactericidal

Sudsing Skin Cleanser

REF MDS093949

latex free Do not reuse

www.medline.com

Manufactured for: Medline Industries, Inc.,

Mundelein, IL 60060 USA Made in USA

To Order Call: 1-800-MEDLINE

2 FL OZ (59 mL)

label

Principal Display Panel

NDC 53329-905-04

Scrub Solution

with Spray Bottle

Povidone Iodine USP, 7.5% Topical Solution

REF MDS093935

Topical Antiseptic

4 FL OZ (118 ml)

label

POVIDONE-IODINE ANTISEPTIC
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-902
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-902-13	59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007	12/31/2016

POVIDONE-IODINE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-905
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
MONOETHANOLAMINE (UNII: 5KV86114PT)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-905-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007	12/31/2016

Labeler - Medline Industries, Inc. (025460908)

Revised: 2/2016

Document Id: 2b947c81-92a2-28c2-e054-00144ff8d46c

Set id: 0f5a2182-9559-4ddd-8dc4-4c8e34796a54

Version: 5

Effective Time: 20160212

Medline Industries, Inc.