Sore Mouth Cleanser

Manufacturer
Vi-Jon, LLC
Effective date
2022-05-17
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 22:00:53

Label at a glance#

ProductSore Mouth Cleanser
Active ingredientHYDROGEN PEROXIDE
Label structure14 sections

Indications and uses

aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums for temporary use to clanse canker sores assists in the removal of foreign material from minor oral wounds

Dosage and administration

adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or pysicial children under 12 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#

TEP

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 150 mg/10mL

Purpose

OTC - PURPOSE SECTION

Oral debriding agent/Oral wound cleanser

Uses

INDICATIONS & USAGE SECTION

  • aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
  • for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
  • for temporary use to clanse canker sores
  • assists in the removal of foreign material from minor oral wounds

Warnings

WARNINGS SECTION

For this product

Do not use

OTC - DO NOT USE SECTION

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 redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

When using this product

OTC - WHEN USING SECTION

do not swallow

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: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or pysicial
  • children under 12 should be supervised in the use of the product
  • children under 2 years of age: consult a dentist or doctor

other information

SPL UNCLASSIFIED SECTION

store at controlled room temperature 68-77°F (20-25°C)

inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, blue 1

Disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse Mild Mint

Adverse Reactions

ADVERSE REACTIONS SECTION

Manufactured by: Vi-Jon, LLC

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA

with US and foreign parts

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain

falls

Compare to Colgate

alcohol

free

cleans and

helps relieve

minor mouth

and gum

irritation

helps reduce

bacteria to

promote better

oral health

hydrogen

peroxide

mouth rinse

oral debriding agent

mint

8 FL OZ (236 mL)

image descriptionimage description

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
0869-04620869-0462-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
10a50e2f-94bb-ca66-e063-6394a90af07e2eb9062f-0944-4730-838a-2dddcb79332c2024-02-05Warnings, Adverse reactionsExact identifier
spl set id: 2eb9062f-0944-4730-838a-2dddcb79332c

Reported adverse events (FAERS/openFDA)#

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