Label: LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION- povidone iodine prep solution 10% liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Warnings

    For external use only

    Do Not Use

    • if allergic to iodine
    • in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Inactive Ingredients

    Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

  • Active Ingredient

    Povidone-iodine 10%

  • Purpose

    Healthcare Antiseptic

  • Use

    For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

  • Directions

    Clean the area. Apply product to the operative site prior to surgery.

  • Other

    Store at controlled room temperature 15º-30ºC (59º-86ºF).

  • Questions?

    1-888-396-2739

  • Labeling

    CR-5667761 IN Master

  • INGREDIENTS AND APPEARANCE
    LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION 
    povidone iodine prep solution 10% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0060
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0060-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/25/2020
    Labeler - Cardinal Health (063997360)
    Registrant - Dynarex Corporation (008124539)
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