Label: POVIDONE IODINE- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2024

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  • Active Ingredient

    Povidone Iodine 10%

  • Purpose

    Antiseptic

  • Uses:

    • First aid to help prevent skin infection in minor cuts, scrapes, and burns
    • Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

  • Warnings:

    For external use only.

  • Do not use:

    • In the eyes
    • Longer than one week unless directed by a doctor
    • On individuals who are allergic or sensitive to iodine
    • Or apply over large areas of the body
  • Ask a doctor before use if you have:

    • Deep or puncture wounds
    • Animal bites
    • Serious wounds
  • Stop use and ask a doctor if:

    • Irritation and redness develops
    • If condition persists for more than 72 hours, consult a physician.


  • Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions:

    Tear at notch. Remove applicator. Discard applicator after single use.

    As a first aid antispetic:

    • Clean affected area
    • Apply 1-3 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 using applicator.

  • Other Information:

    • Store at room temperature
    • Avoid excessive heat
  • Inactive Ingredients

    Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, Water

  • Principal Display Panel

    PROCURE

    HEALTHCARE PRODUCTS

    POVIDONE

    IODINE

    PREP PAD

    Antiseptic

    100 PADS

    123

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-751
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-751-0010 in 1 CASE05/25/2023
    1100 in 1 BOX
    10.1 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/25/2023
    Labeler - TwinMed LLC (009579330)
    Registrant - TwinMed LLC (009579330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Mexico SAPI de CV951575186manufacture(55681-751)
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