DenMat Hydrogen Peroxide Oral Rinse

Manufacturer
Den-Mat Holdings, LLC
Effective date
2022-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:02:06

Label at a glance#

ProductDenMat Hydrogen Peroxide Oral Rinse
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Storage and handling

Other information store at controlled room temperature 68 – 77ºF (20 – 25ºC)

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 to cleanse or facilitate healing of minor mouth irritations, such as canker sores, minor wounds or 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

When using this product, 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

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.

DOSAGE & ADMINISTRATION SECTION

Directions
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 SECTION

Other information store at controlled room temperature 68 – 77ºF
(20 – 25ºC)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions? 800-433-6628

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

64 oz back label64 oz back label64 oz front label64 oz front label

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
59883-20259883-202-64, 59883-202-28, 59883-202-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
0daa2e81-6dcb-4a67-e063-6294a90a1f8cde0f54b0-a825-a090-e053-2995a90aeb322023-12-29WarningsExact identifier
spl set id: de0f54b0-a825-a090-e053-2995a90aeb32

Reported adverse events (FAERS/openFDA)#

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