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% (equivalent 1% titratable Iodine)

  • Purpose

    Antiseptic

  • Uses:

    • First aid to help prevent 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 burns
  • 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 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 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

    Single Pack

    POVIDONE IODINE

    SWABSTICKS

    Antiseptic

    50 Swabsticks Per Box

    10 Boxes Per Case

    500 Swabsticks Total

    132

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-752
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-752-00100 in 1 CASE05/30/2023
    150 in 1 BOX
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/30/2023
    Labeler - TwinMed LLC (009579330)
    Registrant - TwinMed LLC (009579330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Mexico SAPI de CV951575186manufacture(55681-752)
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