FDA.reportPublic FDA data

PEROXY SHIELD MOUTH SORE

Manufacturer
Dental Technologies, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:42:01

Label at a glance#

ProductPEROXY SHIELD MOUTH SORE
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 under 2 years of age or older: rinse 10mL around in the mouth over the 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.

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 cleaner

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.

Warnings

OTC - DO NOT USE SECTION

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

Warnings

OTC - WHEN USING SECTION

When using this product, do not swallow.

Warnings

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

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • Children under 12 years of age: consult a dentist of 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 under 2 years of age or older: rinse 10mL around in the mouth over the 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.

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 1-800-835-0885

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

PEROXY SHIELD®

1.5% HYDROGEN PEROXIDE

MOUTH SORE RINSE

HELPS PROMOTE

A CLEANER MOUTH & HEALING OF

  • ORAL SORES
  • IRRITATIONS
  • MOUTH BURNS

MINT FLAVOR

REF. 035-0101-002

63.0 FL. OZ. (1863 mL)

Peroxy_image.jpgPeroxy_image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199011hydrogen peroxide 1.5 % Oral SolutionPSN5
2480895PEROXY SHIELD 1.5 % Oral SolutionPSN5
2480895hydrogen peroxide 15 MG/ML Oral Solution [Peroxy Shield]SBD5
199011hydrogen peroxide 15 MG/ML Oral SolutionSCD5
199011hydrogen peroxide 1.5 % Oral SolutionSY5
2480895Peroxy Shield 1.5 % Oral SolutionSY5
2480895Peroxy Shield 15 MG/ML Oral SolutionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-3501-1PEROXY SHIELD MOUTH SORE1863 mL in 1 BOTTLE, PLASTICRINSE18635
55346-3501-2PEROXY SHIELD MOUTH SORE473 mL in 1 BOTTLERINSE4735

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
55346-350155346-3501-1, 55346-3501-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
METHYL SALICYLATELAV5U5022YIACT
SUCRALOSE96K6UQ3ZD4IACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
MENTHOLL7T10EIP3AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42023-11-13full-release2026-06-01 00:04:58

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
PEROXY SHIELD MOUTH SORE1.5% HYDROGEN PEROXIDEDental Technologies, Inc.a72e433b-1b7d-4a0c-e053-2995a90a30c42025-11-04WarningsExact identifier
ndc (package): 55346-3501-1
ndc (package): 55346-3501-2
ndc (product): 55346-3501
ndc11 (package): 55346350102
ndc11 (package): 55346350101
spl id: 42c86f95-5c63-ba41-e063-6294a90af8c6
spl set id: a72e433b-1b7d-4a0c-e053-2995a90a30c4

Reported adverse events (FAERS/openFDA)#

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