Label: POVIDINE IODINE swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 12, 2022

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  • Active Ingredient

    Povidone Iodine 10% w/v (9.85% w/w)                     

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns.
    • For preparation of the skin prior to surgery.
    • Helps reduce bacteria that can potentially cause skin infections.
  • Warnings

    For external use only

    Do not use

    • in the eyes.
    • as a first aid antiseptic for more than 1 week.
    • 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

    • condition worsens or persists for more than 72 hours
    • Irritation and redness develop

    Keep out of reach of children

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

  • Other information:

    • Store at room temperature.
    • Avoid excessive heat
  • Inactive ingredients

    Citric acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate USP, Sodium Phosphate Dibasic, Water

  • Principal Display Panel

    Reorder No. 1108

    Povidone - Iodine Prep Pads

    Antiseptic/Germicide

    For External Use Only

    dynarex

    100 Medium

    Label

  • INGREDIENTS AND APPEARANCE
    POVIDINE IODINE 
    povidine iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-420-010.3 g in 1 POUCH; Type 0: Not a Combination Product09/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/13/2016
    Labeler - Dynarex Corporation (008124539)
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