Label: DYNAREX POVIDONE IODINE PREP SOLUTION- povidone iodine prep solution liquid

  • NDC Code(s): 67777-141-30, 67777-141-31, 67777-141-40, 67777-141-41, view more
    67777-141-50, 67777-141-51, 67777-141-60, 67777-141-61
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2024

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  • 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

  • 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 right away.

  • Directions

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

  • Other

    Store at controlled room temperature.

  • Inactive Ingredients

    Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

  • Questions?

    1-888-DYNAREX

  • Labeling

    1413 Label

  • INGREDIENTS AND APPEARANCE
    DYNAREX POVIDONE IODINE PREP SOLUTION 
    povidone iodine prep solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-141
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-141-3148 in 1 CASE05/08/2018
    1NDC:67777-141-30118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67777-141-4124 in 1 CASE05/08/2018
    2NDC:67777-141-40237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:67777-141-5124 in 1 CASE05/08/2018
    3NDC:67777-141-50473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:67777-141-614 in 1 CASE05/08/2018
    4NDC:67777-141-603790 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/08/2018
    Labeler - Dynarex Corporation (008124539)
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