POVIDONE IODINE- povidone-iodine swab

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by PSS World Medical, Inc., Dalian Good Wood Medical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone Iodine USP, 10% w/v

(equipvalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

• Health-care antisptic for preparation of the skin prior to surgery
• First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Warnings

For external use only.

Do not use

Do not use or apply

• in the eyes
• on individuals who are allergic or sensitive to iodine
• over large areas of the body
• as a first aid antiseptic longer than 1 week unless directed by a doctor

Stop use and consult a doctor

Discontinue use if irritation and redness develop.

Consult a doctor in case of

• deep or puncture wounds
• animal bites
• serious burns

Stop use and cosult a doctor if the condition persists or gets worse.

Keep out of reach of children

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, remove swab by stick, apply to the operative site prior to surgery.

For use as a 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

Store at room temperature: 15-30C (59-86F)

Inactive Ingredients

Citrict Acid, Glycerin, Nonoxynol-8, Purified Water, Sodium Hydroxide

Questions

Questions about Select? 800-777-4908

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Made in China

Package Label

986 Each

9986 Box

68345-863-01

1 each/pouch

50 pouches/box

68345-863-03

3 each/pouch

25 pouches/box

PPovidone Iodine, USP Swabsticks

AAntiseptic Germicide Sterile

• Topical pre-surgical and first aid antiseptic swabstick
• For hospital and professional use only

Single use only. Sterile unless package is opened or damaged.

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68345-863
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-8 (UNII: OSD2GAP7HY)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68345-863-01	2 mL in 1 POUCH
2	NDC: 68345-863-03	6 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/05/2012

Labeler - PSS World Medical, Inc. (101822682)

Registrant - PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Business Operations
Dalian Good Wood Medical Ltd.		529575699	manufacture(68345-863)