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 right away.

Directions

Apply topically as needed. Follow with application of Medline Prep Solution and allow to dry.

Other information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Ammonium Nonoxynol-4 Sulfate, Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water

Package Label

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-938
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
NONOXYNOL-5 (UNII: ED8J5T817W)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-938-06	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2017
2	NDC: 53329-938-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2017
3	NDC: 53329-938-23	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2017
4	NDC: 53329-938-25	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2017
5	NDC: 53329-938-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2017

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

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Medline Industries, Inc.		079800021	manufacture(53329-938)