Label: POVIDONE IODINE- povidone iodine oral rinse 0.5% liquid

  • NDC Code(s): 0395-9136-23, 0395-9136-98
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine 0.5%

    (0.05% available iodine)

  • Purpose

    Oral Antiseptic

  • Use

    For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.

  • Warnings

    Do not use this product

    • for more than 7 days unless directed by a dentist of doctor
    • in children under 12 years of age unless directed by a dentist or doctor
    • if you are allergic to povidone-iodine or any other ingredients in this product
    • if you have any thyroid conditions
  • Stop use and consult a doctor if

    Symptoms do not improve in 7 days.

    Irritation, pain or redness persists or worsens.

    Swelling, rash or fever develops.

  • When using this product do not

    Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor.

    Swallow.

    Use with hydrogen peroxide.

  • Keep out of reach of children.

    In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use full strength.
    • Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
    • Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
    • With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
  • Other information

    • Store at 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F).
    • May stain clothing or dental work.
    • Avoid contact with jewelry, especially silver.
  • Inactive Ingredients

    Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.

  • Do not use this product

    • For more than 7 days unless directed by a dentist or doctor.
    • If you are allergic to povidone-iodine or any other ingredients in this product.
    • If you have any thyroid conditions.
  • If pregnant or breast-feeding

    Ask a health professional before use.

  • Purdue Oral Rinse Label

    Betadine 20 mLOral Rinse.jpg

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine oral rinse 0.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9136-98237 mL in 1 CONTAINER; Type 0: Not a Combination Product01/06/2021
    2NDC:0395-9136-2320 mL in 1 CONTAINER; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/06/2021
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-9136) , analysis(0395-9136) , pack(0395-9136) , label(0395-9136)
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