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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 17, 2022

If you are a consumer or patient please visit this version.

  • 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 not finalpart333A01/06/2021
    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)