Henry Schein Mouth

Manufacturer
Henry Schein Inc.
Effective date
2023-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:37

Label at a glance#

ProductHenry Schein Mouth
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Indications and uses

For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

Dosage and administration

For adults and children 2 years of age or older: rinse 10mL around in the mouth over the affected area for at least 1 minute, than split out. Use up to 4 times daily after meals and at bed time, or as directed by a dentist or physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5% (w/w)

Purpose(s)

OTC - PURPOSE SECTION

Oral debriding agent/oral wound cleanser

Uses

INDICATIONS & USAGE SECTION

  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product, do not swallow.

OTC - STOP USE SECTION

Stop use and ask your 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.

  • Children under 2 years of age: consult a dentist or physician.
  • Children under 12 years of age should be supervised in the use of the product.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For adults and children 2 years of age or older: rinse 10mL around in the mouth over the affected area for at least 1 minute, than split out.
  • Use up to 4 times daily after meals and at bed time, or as directed by a dentist or physician.

Other information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.
  • For your protection, do not use if tamper evident seal under the cap is damaged or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-472-4346

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Henry Schein® REF 570-2584

MOUTH RINSE

  • 1.5% HYDROGEN PEROXIDE
  • ALCOHOL FREE

Enjuague bucal

  • 1,5 % Peróxido de hidrógeno
  • Sin alcohol

Bain de bouche

  • 1,5 % De peroxyde d'hydrogène
  • Sans alcool

NDC 0404-0012-01

Mint

Menta

Menthe

16 fl. oz.

(473mL)

Distributed by:

HENRY SCHEIN INC.

135 DURYEA ROAD

Melville, NY 11747 USA

MADE IN USA

Rev.2021/05

Mouth_Rinse_label.jpgMouth_Rinse_label.jpg

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-00120404-0012-01

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
12f14093-bde0-451e-e063-6394a90a43e3c5fbbd40-2acc-2fc3-e053-2a95a90ae9272024-03-05WarningsExact identifier
spl set id: c5fbbd40-2acc-2fc3-e053-2a95a90ae927

Reported adverse events (FAERS/openFDA)#

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