Label: BETADINE ANTISEPTIC ORAL RINSE- povidone-iodine solution

  • 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 February 9, 2021

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

  • Drug Facts

    Active ingredient

    Povidone-iodine, 0.5% (0.05% available iodine)

  • Purpose

    Oral Antiseptic

    Uses

    • 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 or 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

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
    • do not swallow
    • do not use with hydrogen peroxide

    Stop use and ask a doctor or dentist if

    • symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

    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 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F)
    • may stain clothing or dental work
    • avoid contact with jewelry, especially silver
  • Inactive ingredients

    citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
    305765-0B

  • PRINCIPAL DISPLAY PANEL

    Betadine Oral Rinse
    NDC: 67618-182-08

    Betadine Oral Rinse label
  • INGREDIENTS AND APPEARANCE
    BETADINE ANTISEPTIC ORAL RINSE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-182
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-182-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/08/2021
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma L.P. (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884MANUFACTURE(67618-182)