Active ingredient

Povidone Iodine 10% (equivalent to 1% available iodine)

Purpose

First Aid 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 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

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Questions

1-800-MEDLINE

Principal Display Panel - Swabstick Singles pouch

NDC53329-945-09

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

latex free

For professional and hospital use.

Contents: 1 Swabstick

Principal Display Panel - Swabstick Singles box

NDC: 53329-945-29

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

Discard appropriately after single use.

Protect from Freezing. Avoid excessive heat. For external use only.

latex free

Contents: 50 Each

Drug Facts Panel - Swabstick Singles box

Principal Display Panel - Swabstick Triples box

NDC 53329-946-75

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Triples

MDS093902

Discard appropriately after single use.

Protect from freezing. Avoid excessive heat. For external use only.

latex free

Contents: 25 Pouches

Drug Facts Panel - Swabstick Triples box

Principal Display Panel - Prep Pads, Medium box

Medline

Antiseptic

Povidone Iodine Prep Pads, Medium

MDS093917

For hospital and professional use.

Contents: 100 Pads

Drug Facts Panel - Prep Pads, Medium box

Principal Display Panel - Prep Pad Bulk case

Povidone Iodine

Prep PADS
Medium Bulk

MDS093918

Contents: 3,000 Each Per Case

Drug Facts Panel - Prep Pad Bulk case

Principal Display Panel - Prep Solution bottle

NDC: 53329-939-13

MEDLINE

PVP Prep Solution

Topical Antiseptic
Povidone-Iodine 10%

MDS093940

latexfree

www.medline.com

Manufactured for: Medline Industries, Inc.

Mundelein, IL 60060 USA Made in USA

To Order Call: 1-800-MEDLINE

RB11CTR

2 FL OZ (59 mL)

Principal Display Panel - Prep Solution label

N: 53329-900-55

Medline

Prep Solution

with

Spray Bottle

Topical Antiseptic

Microbicide

MDS093942

latex free

Do not reuse

2 FL OZ (59 mL)

Principal Display Panel - Prep Solution label

NDC 53329-904-04

Medline

Prep Solution

with Spray Bottle

Povidone Iodine USP, 10% Topical Solution

MDS093934

Topical Antiseptic

4 FL Oz (118 ml)

POVIDONE-IODINE SWABSTICKS SINGLES
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-945
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Povidone-Iodine	0.10 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description
Packaging
1	NDC:53329-945-29	50 in 1 BOX
1	NDC:53329-945-09	1 in 1 PACKET

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 SWABSTICKS TRIPLES
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-946
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Povidone-Iodine	0.10 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description
Packaging
1	NDC:53329-946-75	25 in 1 BOX
1	NDC:53329-946-02	3 in 1 PACKET

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
povidone-iodine swab

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)	Povidone-Iodine	0.10 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-941-30	100 in 1 BOX

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 swab

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)	Povidone-Iodine	0.10 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description
Packaging
1	NDC:53329-940-97	3000 in 1 CASE
1	NDC:53329-940-09	1 in 1 PACKET

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 TOPICAL ANTISEPTIC
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-939
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Povidone-Iodine	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:53329-939-44	118 mL in 1 BOTTLE, PLASTIC
2	NDC:53329-939-06	473 mL in 1 BOTTLE, PLASTIC
3	NDC:53329-939-08	237 mL in 1 BOTTLE, PLASTIC
4	NDC:53329-939-23	946 mL in 1 BOTTLE, PLASTIC
5	NDC:53329-939-25	3785 mL in 1 BOTTLE, PLASTIC
6	NDC:53329-939-69	88 mL in 1 BOTTLE, PLASTIC
7	NDC:53329-939-13	59 mL in 1 BOTTLE, PLASTIC

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

PREP SOLUTION TOPICAL ANTISEPTIC
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-900
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Povidone-Iodine	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Citric Acid (UNII: 2968PHW8QP)
Sodium Citrate (UNII: 1Q73Q2JULR)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:53329-900-13	59 mL in 1 BOTTLE, PLASTIC
2	NDC:53329-900-55	59 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007	08/31/2014

PREP SOLUTION WITH SPRAY BOTTLE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-904
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Povidone-Iodine	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Citric Acid (UNII: 2968PHW8QP)
Sodium Citrate (UNII: 1Q73Q2JULR)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-904-04	118 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007	08/31/2014

Labeler - Medline Industries, Inc. (025460908)