Label: POVIDONE IODINE- povidone-iodine swab
- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 2, 2012
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- Active Ingredient
Povidone Iodine USP, 10% w/v
(equipvalent to 1% titratable iodine)Close
- Health-care antisptic 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
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.
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.Close
- Other information
Store at room temperature: 15-30C (59-86F)Close
- Inactive Ingredients
Citrict Acid, Glycerin, Nonoxynol-8, Purified Water, Sodium HydroxideClose
Questions about Select? 800-777-4908
Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Made in ChinaClose
- Package Label
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.Close
- INGREDIENTS AND APPEARANCE
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)