POVIDONE-IODINE CLEANING SCRUB SWABSTICK 1 AND 3 SWABSTICKS- providone iodine stick

Povidone-Iodine Cleaning scrub Swabstick by

Drug Labeling and Warnings

Povidone-Iodine Cleaning scrub Swabstick by is a Otc medication manufactured, distributed, or labeled by Professional Disposables International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone-Iodine USP 7.5% w/w (equivalent to 0.75% titratable iodine)

Purpose

Antiseptic

Uses

• A broad spectrum antiseptic for scrubbing the skin prior to surgery.
• First Aid antiseptic to help prevent the risk of skin infection in minor cut, scrapes and burns.

Warnings

For external use only

Do not use

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

Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider

Consult a healthcare provier in case of

• Deep or puncture wounds
• animal bites
• serious burns
• if you are pregnant

Avoid pooling

Directions

For scrubbing the skin prior to surgery

• clean treatment area
• remove applicator
• scrub area as needed
• allow to dry

Other information

• Store at room temperature
• Avoid excessive heat

Inactive ingredients

Octoxynol-9, Purified Water, Sodium Hydroxide

Questions?

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376
USA - 1-800-999-6423
www.pdipdi.com        

Made in USA of Domestic and Impored Materials

KEEP OUT OF REACH OF CHILDREN

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

Principal Display Panel and Labels

Packet 1 swabstick

Box 1 swabstick

Packet 3 swabsticks

Box 3 swabsticks

Packet used in duo-swabstick:

(please refer to NDC: 10819-3890 for the step 2)

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE CLEANING SCRUB SWABSTICK  1 AND 3 SWABSTICKS
providone iodine stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10819-3891
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
WATER (UNII: 059QF0KO0R)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10819-3891-2	50 in 1 BOX	11/01/2011
1		2.5 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 10819-3891-3	25 in 1 BOX	11/01/2011
2		6.5 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 10819-3891-1	25 in 1 BOX	11/01/2011
3		5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1978

Labeler - Professional Disposables International, Inc. (800777117)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposables International, Inc.		800777117	manufacture(10819-3891)