Label: MEDLINE NASAL ANTISEPTIC SWABS- povidone iodine swabstick solution

  • NDC Code(s): 53329-497-26, 53329-497-42, 53329-497-66
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Active ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Uses

    • • antiseptic skin preparation
    • • helps reduce bacteria that can potentially 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

    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 excessive heat. Store at room temperature.

  • Directions

    NASAL APPLICATION:

    Figure
    • Use a tissue to clean the inside of both nostrils, including the inside tip of nostril. Discard.

    Figure
    • Insert swab comfortably into one nostril and rotate for 30 seconds, covering all surfaces. Discard swabstick.

    Figure
    • Using a 2nd swab, repeat step 2 with the other nostril.

    Figure
    • Repeat the application in both nostrils, using the 3rd and 4th swabs.

    Figure
    • Do not blow nose. If solution drips, gently wipe with a tissue.
  • Other information

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

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

  • Manufacturing Information

    Manufactured by:

    Medline Industries, LP

    Three Lakes Drive, Northfield IL 60093 USA

    Made in USA

    1-800-MEDLINE (633-5463)

    REF: MDS1982

    V1 RG22APL

  • Package Label

    Label Front

    Label Back

  • INGREDIENTS AND APPEARANCE
    MEDLINE NASAL ANTISEPTIC SWABS 
    povidone iodine swabstick solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-497
    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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-497-422 in 1 BOX01/15/2018
    1NDC:53329-497-2610 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-497-66250 in 1 CASE01/15/2018
    2NDC:53329-497-2610 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53329-497-2610 mL in 1 PACKET; Type 0: Not a Combination Product01/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/15/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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