Label: BETADINE SOLUTION- povidone-iodine solution

  • NDC Code(s): 67618-150-08, 67618-150-18
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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  • Drug Facts

    Active ingredient

    Povidone-iodine, 10% (1% available iodine)

  • Purpose

    First aid antiseptic

  • Uses

    First aid to helpprevent infection in minor

    • cuts
    • scrapes
    • burns
  • WarningsFor external use only

  • Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to povidone-iodine or any other ingredientsin this preparation
  • Ask a doctor before useif you have

    • deep or puncture wounds
    • serious burns
    • animal bites
  • Stop use and ask a doctor if

    • the condition persists or gets worse
    • you need to use this product for more than 1 week
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, getmedical help or contact a Poison Control Center right away

  • Directions

    • clean the affected area
    • apply a small amount of product to the area 1 to 3 timesdaily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
  • Inactive ingredients

    citric acid, disodiumphosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Dist.by:
    Avrio Health L.P.
    Stamford, CT 06901-3431

    305541-0D

  • PRINCIPAL DISPLAY PANEL

    BetadineSolution 6 fl oz Bottle
    NDC: 67618-150-18

    Betadine Solution 6fl oz Bottle

    BetadineSolution 8 fl oz Bottle
    NDC: 67618-150-08 Betadine Solution Bottle

  • INGREDIENTS AND APPEARANCE
    BETADINE  SOLUTION
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-150
    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, MONOHYDRATE (UNII: BWZ7K44R51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-150-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    2NDC:67618-150-18177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/01/1980
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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