Label: POVIDONE-IODINE TOPICAL ANTISEPTIC- povidone-iodine solution

  • NDC Code(s): 53329-939-04, 53329-939-06, 53329-939-08, 53329-939-13, view more
    53329-939-23, 53329-939-25, 53329-939-69
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2024

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  • Active ingredient

    Povidone Iodine 10%

    (equivalent to 1% available iodine)

  • Purpose

    Antiseptic

  • Uses

    • healthcare antiseptic for preparation of the skin prior to surgery
    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • Warnings

    For external use only.

    Do not use

    • in the eyes
    • longer than 1 week unless directed by a doctor
    • on individuals who are allergic or sensitive to iodine
    • or apply over large areas of the body

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
    • in case of deep or puncture wounds, animal bites or serious burns

    Keep out of reach of children.

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

  • Directions

    Clean the affected area.

    • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
    • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
  • Other information

    • protect from freezing, avoid excessive heat
  • Inactive ingredients

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • Manufacturing Information

    Manufactured by:

    Medline Industries, LP

    Three Lakes Drive, Northifeld, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MDS093941

    V1 RB22DYN

    REF: 55114
    V2 RB24HND

  • Packaging Labels

    PDP

    V2 RB24HND

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE  TOPICAL ANTISEPTIC
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-939
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-939-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2017
    2NDC:53329-939-06473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    3NDC:53329-939-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    4NDC:53329-939-23946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    5NDC:53329-939-253785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    6NDC:53329-939-6988 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    7NDC:53329-939-1359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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