POVIDONE-IODINE CLEANING SCRUB SWABSTICK 1 AND 3 SWABSTICKS- providone iodine stick
Professional Disposables International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PVP-I Scrub

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

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

Principal Display Panel and Labels

Packet 1 swabstick

packet 1

Box 1 swabstick

box 1

Packet 3 swabsticks

packet 3

Box 3 swabsticks

bo x3

Packet used in duo-swabstick:

duo

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

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

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10819-3891-2	50 in 1 BOX	11/01/2011	06/01/2023
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	03/13/2023
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	03/13/2023
3		5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/1978	06/01/2023

Labeler - Professional Disposables International, Inc. (800777117)

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

Revised: 3/2023

Document Id: f6cd206d-c5df-7924-e053-6294a90a7530

Set id: 300c1c06-4dcd-41f9-bcb9-dec1308e08d6

Version: 6

Effective Time: 20230313

Professional Disposables International, Inc.