POVIDONE IODINE, USP SWABSTICKS (3'S) ANTISEPTIC GERMICIDE

POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE by

Drug Labeling and Warnings

POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE by is a Otc medication manufactured, distributed, or labeled by PSS World Medical, Dalian Good Wood Medical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE- povidone-iodine swab 
PSS World Medical

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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POVIDONE IODINE, USP SWABSTICKS (3'S) ANTISEPTIC GERMICIDE

DRUG FACTS

ACTIVE INGREDIENT

Povidone Iodine USP, 10% w/v

(equivaent to 1% titratable iodine)

Purpose

Antiseptic

USES  

health care antiseptic 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

For external use only. 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.

Discontinue use if irritation and redness develop.

Consult a doctor in case of deep puncture wounds

animal bites

serious burns

Stop use and consult 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.

For preparation of the skin prior to surgery clean the affected area, remove the 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 degrees - 30 degreesC (59-86 degrees F)

Inactive Ingredients

citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

Questions about Select? 800-777-4980

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Made in China www.myselectonline.com

POVIDONE IODINE, USP SWABSTICKS (3'S)

ANTISEPTIC GERMICIDE

Topical presurical and first aid antiseptic swabstick

For hospital and professional use only

3 each/pouch

Reorder No. 134

POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68345-862
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68345-862-03	10 in 1 CASE	05/12/2010	12/31/2016
1		25 in 1 BOX
1		100 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/12/2010	04/01/2020

Labeler - PSS World Medical (101822682)

Establishment
Name	Address	ID/FEI	Business Operations
Dalian Good Wood Medical Ltd.		529575699	manufacture(68345-862)

Revised: 12/2017

Document Id: 615199fe-4bb4-5252-e053-2991aa0a47c3

34390-5

Set id: e340ddea-95f5-4c9b-b8e4-63ca013ba5fb

Version: 4

Effective Time: 20171227

 

PSS World Medical