POVIDONE-IODINE PREP STERILE- povidone-iodine sponge

Povidone-Iodine Prep Sterile by

Drug Labeling and Warnings

Povidone-Iodine Prep Sterile by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-Iodine USP 10%

Purpose

Antiseptic

Use

For preparation prior to surgery Helps to reduce bacteria that can potentially cause skin infection.

Warnings

For external use only.

Do not apply to persons allergic to iodine

Do not use

in the eyes

Ask a doctor before use if injuries are

deep wounds puncture wounds serious burns

Stop use and ask a doctor if

irritation and redness develop condition persists for more than 72 hours infection occurs

Avoid pooling beneath the patient.

Prolonged exposure to wet solution may cause skin irritation.

Keep out of reach of children.

If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions

Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Other information

1% titratable iodine latex free for hospital or professional use only

Inactive ingredients

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water

Product Label

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP STERILE 
povidone-iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-658
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-658-11	80 g in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	04/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/30/2015

Labeler - Cardinal Health (097537435)