Label: POVIDONE IODINE- povidone-iodine swab
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Contains inactivated NDC Code(s)
NDC Code(s): 68345-863-01, 68345-863-03 - Packager: PSS World Medical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 2, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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
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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
- Inactive Ingredients
- Questions
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Package Label
986 Each
9986 Box68345-863-01
1 each/pouch
50 pouches/box
68345-863-03
3 each/pouch
25 pouches/box
PPovidone Iodine, USP Swabsticks
AAntiseptic Germicide Sterile
- Topical pre-surgical and first aid antiseptic swabstick
- For hospital and professional use only
Single use only. Sterile unless package is opened or damaged.
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INGREDIENTS AND APPEARANCE
POVIDONE IODINE
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-863 Route of Administration TOPICAL 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)