Hydrogen Peroxide Oral Rinse

Manufacturer
Den-Mat Holdings, LLC
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:22

Label at a glance#

ProductHydrogen Peroxide Oral Rinse
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Dosage and administration

Adults and children 6 years of age and older: fill dose cup to 10 mL (two teaspoons) and rinse around in the mouth over affected area 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 physician Children under 12 years of age should be supervised in the use of the product Children under 6 years of age: consult a dentist or physician

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5% (w/v)

OTC - PURPOSE SECTION

Bacteria reducing rinse and oral debriding agent/oral wound cleanser

INDICATIONS & USAGE SECTION

For temporary use to reduce bacteria in the mouth before and after dental procedures. Other uses include removal of oral debris and cleansing or healing of minor mouth irritations, such as canker sores, minor wounds and minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury or other irritations of the mouth and gums.

WARNINGS SECTION

Do not use this product for more than 7 days unless directed by a dentist or physician.

OTC - WHEN USING SECTION

do not swallow

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore mouth symptoms do not improve within 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

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 6 years of age and older: fill dose cup to 10 mL (two teaspoons) and rinse around in the mouth over affected area 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 physician
  • Children under 12 years of age should be supervised in the use of the product
  • Children under 6 years of age: consult a dentist or physician

Other Information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Water, glycerin, sodium citrate, cremophor RH 40, flavor, tego betain ZF, citric acid, sodium benzoate, sodium fluoride, xylitol, sodium hydroxide

OTC - QUESTIONS SECTION

800-433-6628

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16 oz label16 oz label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199011hydrogen peroxide 1.5 % Oral SolutionPSN1
199011hydrogen peroxide 15 MG/ML Oral SolutionSCD1
199011hydrogen peroxide 1.5 % Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-201-16Hydrogen Peroxide Oral Rinse473 mL in 1 BOTTLE, DISPENSINGLIQUID4731
59883-201-28Hydrogen Peroxide Oral Rinse3785 mL in 1 BOTTLE, DISPENSINGLIQUID37851
59883-201-64Hydrogen Peroxide Oral Rinse1893 mL in 1 BOTTLE, DISPENSINGLIQUID18931

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-201HYDROGEN PEROXIDE ORAL RINSE LIQUID [DEN-MAT HOLDINGS, LLC]1Legacy NDC, 3 package rows20200821_ad4460cc-6c17-606d-e053-2a95a90ae31f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-20159883-201-28, 59883-201-64, 59883-201-16

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
ad4460cc-6c18-606d-e053-2a95a90ae31fad4460cc-6c17-606d-e053-2a95a90ae31f2020-08-19WarningsExact identifier
spl id: ad4460cc-6c18-606d-e053-2a95a90ae31f
spl set id: ad4460cc-6c17-606d-e053-2a95a90ae31f

Reported adverse events (FAERS/openFDA)#

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