Oral Sore Antiseptic

Manufacturer
Retail Business Services, LLC | Nice-Pak Products, LLC
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:37:22

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 occ...

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

Storage and handling

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

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 mouth

Warnings

WARNINGS SECTION

for this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ 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

STORAGE AND HANDLING SECTION

  • 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

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contact us at 1-833-992-3872

Quality guaranteed or your money back.

*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse Mouth Sores.

DSP-TN-21091   DSP-MO-20087

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

Compare to Orajel Antispetic Rinse Mouth Sores*

ORAL SORE

ANTISEPTIC RINSE

ORAL PAIN RELIEVER

ORAL DEBRIDING AGENT

FOR MOUTH SORES, INCLUDING GUM IRRITATION FROM BRACES OR DENTURES AND CANKER SORES

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

NET 16 FL OZ (1 PT) 473 mL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionPSN6
2584344hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCD6
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-024-43Oral Sore Antiseptic473 mL in 1 BOTTLE, PLASTICLIQUID4736

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
72476-02472476-024-43

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
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 72476-024-43
ndc (product): 72476-024
ndc11 (package): 72476002443
spl id: 4a2a92e5-2777-17b9-e063-6394a90af80c
spl set id: d46546d0-c6df-431a-8ab0-bc5013c084d7

Reported adverse events (FAERS/openFDA)#

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