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
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

Manufacturing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northifeld, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS093941

V1 RB22DYN

REF: 55114
V2 RB24HND

Packaging Labels

PDP

V2 RB24HND

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)	IODINE	10 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-939-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/27/2017
2	NDC:53329-939-06	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2007
3	NDC:53329-939-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2007
4	NDC:53329-939-23	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2007
5	NDC:53329-939-25	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2007
6	NDC:53329-939-69	88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2007
7	NDC:53329-939-13	59 mL in 1 BOTTLE, PLASTIC; 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 Drug	505G(a)(3)	01/01/2007

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

939 PVP Prep Solution