Betadine

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:38:58

Label at a glance#

ProductBetadine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine, 0.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warning

WARNINGS SECTION

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 SECTION

For the temporary relief of occasional sore throat

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-833-288-2684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine 8OZ GargleBetadine 8OZ Gargle

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0181BETADINE (POVIDONE IODINE) LIQUID [XTTRIUM LABORATORIES, INC.]2Unmatched20250519_2659a220-bc71-3b40-e063-6394a90a37d4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-01810116-0181-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
34006d99-6184-06d3-e063-6294a90ab07a2659a220-bc71-3b40-e063-6394a90a37d42025-04-30WarningsExact identifier
spl id: 34006d99-6184-06d3-e063-6294a90ab07a
spl set id: 2659a220-bc71-3b40-e063-6394a90a37d4

Reported adverse events (FAERS/openFDA)#

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