FDA.reportPublic FDA data

BETADINE Antiseptic Oral Rinse

Manufacturer
Atlantis Consumer Healthcare, Inc. | Pharma Nobis, LLC
Effective date
2023-06-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:30:09

Label at a glance#

ProductBETADINE Antiseptic Oral Rinse
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Dosage and administration

Use full strength Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out. Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out. With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival m...

Storage and handling

store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) may stain clothing or dental work avoid contact with jewelry, especially silver

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

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

Purpose

OTC - PURPOSE SECTION

Oral Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction

Warnings

WARNINGS SECTION

Do not use this product

OTC - DO NOT USE SECTION

  • for more than 7 days unless directed by a dentist or doctor
  • in children under 12 years of age 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

When using this product

OTC - WHEN USING SECTION

  • 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 or dentist if

OTC - STOP USE SECTION

  • symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use full strength
  • Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
  • Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
  • With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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
305765-0B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Oral Rinse
NDC: 67618-182-08

Betadine Oral Rinse label
Betadine Oral Rinse label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-182-08ML - Milliliter67618-18219e52863-5d8b-493c-9818-4dea735a363f12021-03-02

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-18267618-182-08

Ingredients#

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

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

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

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
2b35c722-769f-89b1-e063-6294a90ad7176ee3fcda-15e5-3754-8ea9-39ba03359ad72025-01-08WarningsExact identifier
spl set id: 6ee3fcda-15e5-3754-8ea9-39ba03359ad7

Reported adverse events (FAERS/openFDA)#

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