Label: POVIDONE IODINE- povidone-iodine swab 

  • Label RSS
  • 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.

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Povidone Iodine USP, 10% w/v

    (equipvalent to 1% titratable iodine)

    Close
  • Purpose

    Antiseptic

    Close
  • Uses

    • 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
    Close
  • 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.

    Close
  • 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.

    Close
  • Other information

    Store at room temperature: 15-30C (59-86F)

    Close
  • Inactive Ingredients

    Citrict Acid, Glycerin, Nonoxynol-8, Purified Water, Sodium Hydroxide

    Close
  • Questions

    Questions about Select? 800-777-4908

    Manufactured for PSS World Medical, Inc.

    4345 Southpoint Blvd., Jacksonville, FL 32216

    Made in China

    Close
  • 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

    • 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
    POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68345-863
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) POVIDONE-IODINE 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    NONOXYNOL-8  
    WATER  
    SODIUM HYDROXIDE  
    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)
    Close