Label: BETADINE GARGLE- 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 October 23, 2020

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

  • Drug Facts

    Active ingredient

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

  • Purpose

    Antiseptic

    Uses

    • For the temporary relief of occasional sore throat
  • Warnings

    Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

    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

    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 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 gargling is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    DO NOT SWALLOW
    Adults and children 12 years and older:

    • Gargle with 10 ml full strength for 30 seconds, then spit out
    • Use only with dosing cup provided
    • Use up to 4 times daily

    Children under 12: Do not use.

  • 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
    305586-0E

  • PRINCIPAL DISPLAY PANEL

    Betadine Gargle Carton
    NDC: 67618-181-08

    Betadine Gargle Carton
  • INGREDIENTS AND APPEARANCE
    BETADINE GARGLE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-181
    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:67618-181-081 in 1 CARTON06/15/2020
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/2020
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884MANUFACTURE(67618-181)