Label: POVIDONE IODINE- povidone iodine gargle 0.5% liquid

  • NDC Code(s): 0395-9128-98
  • 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 June 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine 0.5%

    (0.05% available iodine)

  • Purpose

    Antiseptic

  • Use

    For the temporary relief of occasional sore throat.

  • Warnings

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting 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.

  • 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 gargling is swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    DO NOT SWALLOW

    Adults and children 12 years and older:

    • Gargle with 10mL 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°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 Gargle Label

    Gargle Label 2022Gargle IFC 2022Gargle Label.jpgGargle.jpg

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine gargle 0.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9128
    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:0395-9128-981 in 1 CARTON06/10/2020
    1237 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-9128) , analysis(0395-9128) , pack(0395-9128) , label(0395-9128)
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