PDI DUO-SWAB POVIDONE-IODINE ANTISEPTIC PREP AND SCRUB SWABSTICKS ONES- povidone iodine stick

PDI Duo-Swab Povidone-Iodine by

Drug Labeling and Warnings

PDI Duo-Swab Povidone-Iodine 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

Scrub: Povidone-iodine USP, 7.5% w/w (equivalent to 0.75% titratable iodine)

Prep: Povidone-iodine USP, 10% w/w (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

Prep:

• a broad spectrum antiseptic for topical application for preparation of skin prior to surgery
• First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns.

Scrub:

• a broad spectrum antiseptic for scrubbing 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

• 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 persists for more than 72 hours or gets worse, consult a healthcare provider

Consult a doctor in case of

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

Stop use and ask a doctor if

the condition persists or gets worse.

Keep out of reach of children.

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

Directions

• clean the treatment area
• remove applicator by end of swabstick
• apply to the operative site prior to surgery / or - scrub as needed
• allow to dry

Other information

Store at room temperature. Avoid excessive heat.

Inactive ingredients

SCRUB: Purified water, Octoxynol-9, Sodium Hydroxide

PREP: Purified Water, Sodium Hydroxide

QUESTIONS

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

Principal Display Panel

Packet Swabstick (1's)

Box Swabstick (1's)

INGREDIENTS AND APPEARANCE

PDI DUO-SWAB POVIDONE-IODINE  ANTISEPTIC PREP AND SCRUB SWABSTICKS ONES
povidone iodine stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10819-3890
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10819-3890-1	5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package	11/01/2011

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(10819-3890)