Label: BETADINE GARGLE- povidone-iodine solution

  • NDC Code(s): 67618-181-08
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 22, 2023

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  • Drug Facts

    Active ingredient

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

  • Purpose

    Antiseptic

    Uses

    • For the temporary relief of occasional sore throat
  • Warnings

    SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto 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 ingredientsin this product
    • if you have any thyroid conditions

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughlywith 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, getmedical help or contact a Poison Control Center right away.

  • Directions

    DO NOT SWALLOW
    Adults andchildren 12 years and older:

    • Gargle with 10 ml full strength for 30 seconds, then spitout
    • 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

    BetadineGargle 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 DrugM02206/15/2020
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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