POVIDONE-IODINE PREP PADS MEDIUM- povidone-iodine cloth
POVIDONE-IODINE PREP PADS MEDIUM BULK- povidone-iodine cloth
Medline Industries, LP

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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940-941 Povidone-Iodine Prep Pads

Active ingredient

Povidone-Iodine, 10% w/w

Purpose

Antiseptic

Uses

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 physician
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
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 assistance or immediately contact a Poison Control Center.

Directions

clean the affected area
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

do not flush
protect from freezing, avoid excessive heat

Inactive ingredients

citric acid, disodium phosphate, water

Principal Display Panel

PDP

Principal Display Panel

PDP2

POVIDONE-IODINE PREP PADS MEDIUM
povidone-iodine cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-941
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-941-30	100 in 1 BOX	01/11/2019
1	NDC:53329-941-09	1 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:53329-941-09	1 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2007

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

POVIDONE-IODINE PREP PADS MEDIUM BULK
povidone-iodine cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-940
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-940-97	3000 in 1 CASE	01/11/2019	05/31/2022
1		1 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:53329-940-09	1 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2007	05/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007	05/31/2022

Labeler - Medline Industries, LP (025460908)