Label: BETADINE- povidone iodine liquid

  • NDC Code(s): 0116-0181-08
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2024

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

  • Active Ingredient

    Povidone-iodine, 0.5%

  • Purpose

    Antiseptic

  • Warning

    Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high
    fever, headache, nausea, and vomiting may be serious. Consult a 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 othe ringredients in this product

    ■ if you have any thyroid condtions
    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

    ■ symptoms do not improve in 7 days

    ■ irritation, pain, or redness persists or worsens

    ■ swelling, rash, or fever develops
    If pregnant or breast-feeding, ask a health professional before use.

  • INDICATIONS & USAGE

    For the temporary relief of occasional sore throat

  • KEEP OUT OF REACH OF CHILDREN

    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 children12 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 25°F (77°F); excursions permitted between 15°-30°C (59°-86°F)
    ■ may stain clothing or dental work
    ■ avoid contact with jewelry, especially silver

  • Inactive Ingredients

    citric acid, flavor, glycenn, propylene glycol, puritied water, saccharin sodium,
    sodium hydroxide.

  • Questions or comments?

    1-833-288-2684

  • PRINCIPAL DISPLAY PANEL

    Betadine Gargle 8oz Betadine Gargle Shelf Carton

  • INGREDIENTS AND APPEARANCE
    BETADINE 
    povidone iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0181
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0181-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02211/07/2024
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-0181)