POVIDONE-IODINE SCRUB SOLUTION- povidone-iodine solution

Povidone-Iodine Scrub Solution by

Drug Labeling and Warnings

Povidone-Iodine Scrub Solution 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 USP 7.5%
(equivalent to 0.75% titratable iodine)

Purpose

Antiseptic / First Aid Antiseptic

Use

• First aid to help prevent skin infection in minor cuts, scrapes, and burns
• For preparation of the skin 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

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

For preparation of the skin prior to surgery

• Clean the affected area
• Apply product to the operative site prior to surgery

For first aid antiseptic

• Clean the affected area
• 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

Disodium Phosphate, Glycerin, Hydroxethyl Cellulose, Monoethanolamine, Deionized Water

Package Label

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE SCRUB SOLUTION 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
MONOETHANOLAMINE (UNII: 5KV86114PT)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-351-08	48 in 1 CASE	08/13/2015	10/31/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 63517-351-06	24 in 1 CASE	08/13/2015	10/31/2020
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 63517-351-03	24 in 1 CASE	08/13/2015	08/31/2020
3		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 63517-351-05	12 in 1 CASE	08/13/2015	07/31/2020
4		946 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 63517-351-07	48 in 1 CASE	08/13/2015	10/31/2020
5		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/13/2015	10/31/2020

Labeler - Cardinal Health (961027315)