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#
Contacts and useful links#
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
- 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
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69951-004-16 | Prevention Mouth Sore Rinse | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Prevention Mouth Sore Rinse
- Hydrogen peroxide
- CITRIC ACID MONOHYDRATE
- WATER
- EDETATE DISODIUM
- GLYCERIN
- MENTHOL
- PEPPERMINT OIL
- POLOXAMER 407
- SODIUM CITRATE
- ZINC CHLORIDE
- POLYSORBATE 20
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69951-004 | 69951-004-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROGEN PEROXIDE | BBX060AN9V | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| WATER | 059QF0KO0R | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| ZINC CHLORIDE | 86Q357L16B | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Prevention Mouth Sore Rinse | HYDROGEN PEROXIDE | Prevention Health Sciences, Inc. | 2eae61e4-1800-5fa6-e063-6394a90a9583 | 2025-01-01 | Warnings | 69951-004-16 69951-004 69951000416 2eae7404-0d19-0c00-e063-6294a90a9929 2eae61e4-1800-5fa6-e063-6394a90a9583 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
