Label: BETADINE SOLUTION- povidone-iodine solution

  • NDC Code(s): 67618-150-01, 67618-150-04, 67618-150-05, 67618-150-09, view more
    67618-150-17, 67618-150-32
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 22, 2023

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  • Drug Facts

    Active ingredient

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

  • Purpose

    Antiseptic

  • Uses

    Patient pre-operative skin preparation

    • 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

    • in the eyes
    • if you are allergic to povidone-iodine or any other ingredientsin this preparation
  • When using this product

    • single use will reduce the risk of infection from extrinsiccontamination
    • prolonged exposure to wet solution may cause irritationor, rarely, severe skin reactions
    • in pre-operative prepping, avoid “pooling” beneath the patient
  • Stop use and ask a doctorif

    • irritation, sensitization, or allergic reaction occurs andlasts for 72 hours. These may be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison ControlCenter right away.

  • Directions

    • single use may prevent extrinsic contamination
    • clean the operative site prior to surgery
    • apply product and allow to dry
    • may be covered with a bandage
  • Other information

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

    pareth 25-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

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

    ©2018, Avrio Health L.P.

  • PRINCIPAL DISPLAY PANEL

    BetadineSolution 8 oz
    NDC: 67618-150-09

    Betadine Solution 8 oz
  • 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
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-150-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    2NDC:67618-150-0514.8 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    3NDC:67618-150-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    4NDC:67618-150-17473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    5NDC:67618-150-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/198008/31/2024
    6NDC:67618-150-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    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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