POVIDONE IODINE- povidone-iodine swab 
PSS World Medical, 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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Povidone Iodine, USP Swabsticks

Active Ingredient

Povidone Iodine USP, 10% w/v

(equipvalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

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

986 Each

986 Box9986 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

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

POVIDONE IODINE 
povidone-iodine swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-863
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 10/2012
Document Id: ba566fab-596d-4c6d-a462-4fe8aa03b7c0
Set id: cc38b404-13f5-467b-888c-929efc61231c
Version: 4
Effective Time: 20121002
 
PSS World Medical, Inc.