FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:39

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure14 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 0.5%

(0.05% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of occasional sore throat.

Warnings

WARNINGS SECTION

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

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case more than used for gargling is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.

Do not use this product

OTC - DO NOT USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Purdue Gargle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314935povidone-iodine 0.5 % MouthwashPSN5
314935povidone-iodine 5 MG/ML MouthwashSCD5
314935povidone-iodine 0.5 % MouthwashSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9128-98Povidone Iodine237 mL in 1 CONTAINERLIQUID2375
0395-9128-98Povidone Iodine1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9128POVIDONE IODINE (POVIDONE IODINE GARGLE 0.5%) LIQUID [HUMCO HOLDING GROUP, INC.]5Current NDC, Legacy NDC, 2 package rows20231216_a7b9ad55-cfeb-6066-e053-2a95a90af975.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91280395-9128-98

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEPPERMINTV95R5KMY2BIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
ndc (package): 0395-9128-98
ndc (product): 0395-9128
ndc11 (package): 00395912898
spl id: 0c9380d5-c284-0902-e063-6394a90ac157
spl set id: a7b9ad55-cfeb-6066-e053-2a95a90af975

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.