Oral Sore Antiseptic

Manufacturer
Old East Main CO. | Vi-Jon, LLC
Effective date
2022-03-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:04:51

Label at a glance#

ProductOral Sore Antiseptic
Active ingredientHYDROGEN PEROXIDE, MENTHOL
Label structure12 sections

Indications and uses

▪ first aid to help protect against bacterial contamination in minor oral wounds ▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪  dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores ▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with oc...

Dosage and administration

Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician Children under 12 years of age - should be supervised in the use of the product Children under 2 years of age - consult a dentist or doctor

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

purpose

OTC - PURPOSE SECTION

Oral debriding agent/Oral antiseptic
Oral pain reliever

uses

INDICATIONS & USAGE SECTION

▪ first aid to help protect against bacterial contamination in minor oral wounds
▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪  dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouthUses
▪ first aid to help protect against bacterial contamination in minor oral wounds

▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures

▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth

warnings

WARNINGS SECTION

Stop use and ask a doctor if
▪ sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
▪ irritation, pain, or redness persists or worsens
▪ swelling, rash, or fever develops
▪ sore mouth symptoms do not improve in 7 days

When using this product

OTC - WHEN USING SECTION

  •  do not swallow 
  •  do not use more than 7 days unless directed by a dentist or doctor 
  •  do not exceed recommended dosage

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician

Children under 12 years of age - should be supervised in the use of the product

Children under 2 years of age - consult a dentist or doctor

other information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 68-77°F (20-25°C) 
  •  keep away from heat or direct sunlight

inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

SAFETY SEAL

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888)309-9030

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1903

Rexall

Oral Sore

Antiseptic

Rinse

  • For mouth sores, including gum irritation from braces or dentures and canker sores
  • Kills germs and bacteria

MINT

FLAVOR

473 mL (16 FL OZ)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-78555910-785-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
ed080bb8-7ea6-43c5-b042-e82ce96964a1211c3b78-18b2-478c-ae15-596eb7a13fae2023-10-04Warnings, Adverse reactionsExact identifier
spl set id: 211c3b78-18b2-478c-ae15-596eb7a13fae

Reported adverse events (FAERS/openFDA)#

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