POVIDONE IODINE PREP- povidone iodine solution

Povidone Iodine Prep by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Povidone Iodine 10%

(equivalent to 1% titratable iodine)

Purpose

Antiseptic/First Aid Antispetic

Uses

• First aid to help prevent skin infection in minor cuts,scrapes, and burns
• For preparation of the skin prior to skin surgery
• Helps to reduce bacteria that can potentially cause skin infection
  

Warnings

For External Use Only.

Do not use

As a first aid antiseptic

• Do not use in the eyes or apply over large areas of the body
• In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
• Stop use and consult a doctor if the condition persists or gets worse
• Do not use longer than 1 week unless directed by a doctor

For preoperative patient skin preparation

• Do not use in the eyes
• Discontinue use if irritation and redness develop
• If condition persists for more than 72 hours, consult a doctor
  

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 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 1-3 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

Principal Display Panel

Povidone-Iodine Prep Solution

Povidone-Iodine 10%

single use only

Cardinal Health

Net Wt. 0.75 fl oz (22.2 mL)

NDC: 63517-132-01

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-132
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-132-01	500 in 1 CASE
1		22.2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/26/2015

Labeler - Cardinal Health (097537435)