Prevention Mouth Sore Rinse

Manufacturer
Prevention Health Sciences, Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:09

Label at a glance#

ProductPrevention Mouth Sore Rinse
Active ingredientHYDROGEN PEROXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Hydrogen peroxide 1.4%

OTC - PURPOSE SECTION

Purpose

Oral debriding agent / Oral wound cleanser

INDICATIONS & USAGE SECTION

Uses

  • Aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth.
  • For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
  • For temporary use to cleanse canker sores.

OTC - DO NOT USE SECTION

Do not use for more than 7 days unless directed by a dentist or doctor

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 2 years of age and older: swish one capful (10 ml) around in mouth over affected area for at least one minute and then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 should be supervised in the use of product.
  • children under 2 years of age: consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

  • keep away from heat or direct sunlight
  • Do not use if safey seal under cap is broken or missing

INACTIVE INGREDIENT SECTION

Inactive ingredients Citric Acid, Disodium EDTA, Glycerin, Menthol, Peppermint Oil, Poloxamer 407, Polysorbate 20, Purified Water, Sodium Citrate, Sucralose, Zinc Chloride

OTC - QUESTIONS SECTION

Questions? call (800) 473-1205

SPL UNCLASSIFIED SECTION

Formulated and Distribured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

PREVENTION™ MOUTH RINSE

Formulated for MOUTH SORE RELIEF

Oral Wound Cleanser For Common Mouth Sores

  • CANKER SORES
  • IRRITATION FROM BRACES
  • MINOR MOUTH INJURIES

Soothing Mint

NET. 16 FL OZ (1 PT) 473 ML

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2705805hydrogen peroxide 1.4 % MouthwashPSN1
2705805hydrogen peroxide 14 MG/ML MouthwashSCD1
2705805hydrogen peroxide 1.4 % MouthwashSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69951-004-16Prevention Mouth Sore Rinse473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69951-004PREVENTION MOUTH SORE RINSE (HYDROGEN PEROXIDE) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1Current NDC, 1 package rows20250228_2eae61e4-1800-5fa6-e063-6394a90a9583.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
69951-00469951-004-16

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
Prevention Mouth Sore RinseHYDROGEN PEROXIDEPrevention Health Sciences, Inc.2eae61e4-1800-5fa6-e063-6394a90a95832025-01-01WarningsExact identifier
ndc (package): 69951-004-16
ndc (product): 69951-004
ndc11 (package): 69951000416
spl id: 2eae7404-0d19-0c00-e063-6294a90a9929
spl set id: 2eae61e4-1800-5fa6-e063-6394a90a9583

Reported adverse events (FAERS/openFDA)#

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