Oral B Mouth Sore

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:05

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

+ WITH HYDROGEN PEROXIDE

Dosing Cup Included

HYDROGEN PEROXIDE ORAL DEBRIDING AGENT

Oral-B

MOUTH SORE

ORAL RINSE

SCIENTIFICALLY

FORMULATED

For Mouth Sores Including:

  • Canker Sores
  • Cheek Bites
  • Braces & Denture Irritations

SOOTHING MINT

475 mL (16 FL OZ)

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90271663capture.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-603-08Oral B Mouth SoreSpecial Care Rinse237 mL in 1 BOTTLE, PLASTICRINSE2377
84126-603-16Oral B Mouth SoreSpecial Care Rinse475 mL in 1 BOTTLE, PLASTICRINSE4757

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-60384126-603-16, 84126-603-08

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-07-31full-release2026-06-01 01:08:59

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
Oral B Mouth Sore Special Care RinseHYDROGEN PEROXIDEThe Procter & Gamble Manufacturing Company22e2dc15-5794-28ed-e063-6394a90a36d32026-01-08WarningsExact identifier
ndc (package): 84126-603-08
ndc (package): 84126-603-16
ndc (product): 84126-603
ndc11 (package): 84126060316
ndc11 (package): 84126060308
spl id: 47e526f6-1f0e-c1dd-e063-6394a90a3888
spl set id: 22e2dc15-5794-28ed-e063-6394a90a36d3

Reported adverse events (FAERS/openFDA)#

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