Label: MEDLINE- povidone-iodine swab

  • NDC Code(s): 53329-120-05, 53329-120-09, 53329-120-26
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 1, 2024

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  • Active Ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Uses

    • antiseptic skin preparation
    • help reduce bacteria that potentially can cause skin infections
  • Warnings

    For external use only.

    Do not use

    • if allergic to iodine
    • in the eyes
    • on children less than 3 years old

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Keep out of reach of children.

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

    Avoid excessive heat.

    Protect from freezing, avoid excessive heat.

    Temperature limits: 15˚C-30˚C.

    Stop use and ask a doctor if

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

    Swab locally as needed.

  • Other information

    • 1% titratable iodine
    • not made with natural rubber latex
    • for hospital or professional use only
    • store product upright
  • Inactive ingredients

    disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

  • Manufacturing Information

    Made in USA by: Medline Industries, LP

    Three Lakes Drive,
    Northfield, IL 60093 USA.

    REF: MDS1982

    1-800-MEDLINE V2 RB24HND

    www.medline.com

  • Label

    label

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-120
    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
    NONOXYNOL-10 (UNII: K7O76887AP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-120-091 in 1 POUCH07/01/2024
    110 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53329-120-264 in 1 BOX07/01/2024
    21 in 1 POUCH
    210 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:53329-120-05250 in 1 CASE07/01/2024
    31 in 1 POUCH
    310 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/01/2024
    Labeler - Medline Industries, LP (025460908)
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