Oral B Mouth Sore

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:24:04

Label at a glance#

ProductOral B Mouth Sore Special Care Rinse
Active ingredientHYDROGEN PEROXIDE
Label structure10 sections

Indications and uses

For temporary use in cleansing minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth. For temporary use to cleanse canker sores.

Dosage and administration

• adults and children 6 yrs. & older: Rinse with 20 mL Swish around in the mouth over the affected area for at least 1 minute and then spit out. Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor. do not swallow children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 1.5%

Purpose

OTC - PURPOSE SECTION

oral debriding/wound cleansing

Uses

INDICATIONS & USAGE SECTION

  • For temporary use in cleansing minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
  • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.
  • For temporary use to cleanse canker sores.

Warnings

WARNINGS SECTION

  • Do not use this product for more than 7 days unless directed by a dentist or doctor.
  • If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 6 yrs. & older:

Rinse with 20 mL

Swish around in the mouth over the affected area for at least 1 minute and then spit out.

Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor.

do not swallow

  • children 6 years to under 12 years of age:

supervise use

  • children under 6 years of age:

do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glycerin, poloxamer 407, propylene glycol, sodium citrate, sodium hexametaphosphate, sodium saccharin, sucralose, water

Questions?

OTC - QUESTIONS SECTION

1-800-862-7442

SPL UNCLASSIFIED SECTION

DISTR. BY ORAL-B, A DIVISION

OF PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral-B

HYDROGEN PEROXIDE ORAL DEBRIDING AGENT

MOUTH SORE

SPECIAL CARE ORAL RINSE

For Mouth Sores Including:

  • Canker Sores
  • Cheek Bites
  • Braces & Denture Irritations
  • Oral & Gum Irritations

SOOTHING MINT

475 mL (16 FL OZ)

962962

Products#

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-96237000-962-16, 37000-962-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
22e24f8b-4778-85d3-e063-6394a90a083ba2b5032a-e142-48ae-e053-2995a90ade742024-09-24WarningsExact identifier
spl set id: a2b5032a-e142-48ae-e053-2995a90ade74

Reported adverse events (FAERS/openFDA)#

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