Label: POVIDONE-IODINE solution

  • NDC Code(s): 53329-943-13, 53329-943-69
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 15, 2022

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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
    • if 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 (1-800-222-1222) 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

    Store at Room Temperature. Protect from freezing. Avoid excessive heat.

  • Inactive Ingredients

    Citric Acid, Disodium Phosphate, Glycerin, Nonylphenol 9, Purified Water, Sodium Citrate

  • Manufacturing Information

    Manufactured for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Made in Mexico
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: 503911
    V1 RK22DEG

  • Package Label

    Label V1 RK22DEG

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-943
    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
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    N-NONYLPHENOL (MIXED ISOMERS) (UNII: 79F6A2ILP5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-943-6988 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2016
    2NDC:53329-943-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/04/2016
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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