Label: POVIDONE IODINE SWABSTICKS 4 TRIPLE- povidone-iodine swab

  • NDC Code(s): 72838-0360-1
  • Packager: Amsino healthcare (USA) inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-lodine USP10%

    Purpose

    Antiseptic

  • Use

    for antiseptic skin preparation

  • Warnings

    • do not use if allergic to iodine
    • do not use in the eyes

    Stop use and ask a doctor if

    • redness,irritation,swelling or pain persists or increases
    • infection occurs

    Keep out of reach of children.

    In case of accidental ingestion,seek professional assistance or consult a poison control center immediately.

    Avoid pooling beneath patient.

    Ask a doctor before use if

    injuries are

    For external use only.

    • deep or puncture wounds
    • serious burns
  • Directions

    apply locally as needed

  • Other information

    • 1% titratable iodine
    • For hospital or professional use only
    • Store at room temperature.
    • Avoid excessive heat.
    • Not made with natural rubber latex.
  • Inactive ingredients:

    Citric Acid,Alkyl Glucoside,Hydroxyethyl Cellulose,Nonoxynol-10,Glycerin,Sodium Hydroxide,Potassium lodide,Purified Water.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE SWABSTICKS 4 TRIPLE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72838-0360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72838-0360-13 in 1 POUCH01/30/2022
    12 g in 1 APPLICATOR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/30/2022
    Labeler - Amsino healthcare (USA) inc. (116914622)
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