Label: POVIDONE IODINE GEL SWABSTICK gel

  • NDC Code(s): 68786-418-01
  • Packager: Sion Biotext Medical Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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

  • Active Ingredient

    Povidone-Iodine 10%

  • Purpose

    Antiseptic

  • Use(s)

    • For preparation of the skin prior to surgery

    • First aid to help prevent infection in minor cuts, scrapes, and burns

    • For venipuncture skin preparation

  • Warnings

    For External Use Only

  • Do not use

    • In the eyes or over large areas of the body

    • Longer than 1 week unless directed by a doctor

  • Ask a doctor before use if you have

    • Deep or puncture wounds

    • Animal bites

    • Serious burns

  • Stop use and ask a doctor if

    Condition persists or gets worse

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

  • Directions

    • Tear at notch • Remove applicator • Use only once

    As a first aid antiseptic:

    • Clean affected area

    • Apply 1 to 3 times daily

    • May be covered with a sterile bandage

    • If bandaged, let dry first

    For preoperative patient skin preparation:

    • Clean area

    • Apply to operative site prior to surgery

    For Venipuncture skin preparation:

    • Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.

    • After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter.

    • Allow site to dry for approximately 30 seconds.

    • If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

  • Other Information

    • Store at room temperature 15º-30ºC (59º-86ºF)

    • Avoid excessive heat

  • Inactive Ingredients

    Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR

  • Questions and Comments?

    1-888-369-2739 M-F, 9-5 EST

  • Label

    NDC 68786-418-01

    Label

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE GEL SWABSTICK 
    povidone iodine gel swabstick gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-418
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-418-0150 in 1 BOX02/01/2024
    10.3 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/01/2024
    Labeler - Sion Biotext Medical Ltd (532775194)