Prevention Mouth Sore Relief

Prevention Mouth Sore Relief
SPL v1
SPL
SPL Set ID 2eae61e4-1800-5fa6-e063-6394a90a9583
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (1.4 g)
Inactive Ingredients
Citric Acid Monohydrate Water Edetate Disodium Glycerin Menthol Peppermint Oil Poloxamer 407 Sodium Citrate Zinc Chloride Polysorbate 20 Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01
Description

Active ingredient Hydrogen peroxide 1.4%

Medication Information

Indications and Usage

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.

Dosage and Administration

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.
Description

Active ingredient Hydrogen peroxide 1.4%

Section 42229-5

Formulated and Distribured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

Section 50565-1

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.

Section 50566-9

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
Section 50570-1

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

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions? call (800) 473-1205

Section 55105-1

Purpose

Oral debriding agent / Oral wound cleanser

Section 55106-9

Active ingredient

Hydrogen peroxide 1.4%

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

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.
Section 42229-5 (42229-5)

Formulated and Distribured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions? call (800) 473-1205

Section 55105-1 (55105-1)

Purpose

Oral debriding agent / Oral wound cleanser

Section 55106-9 (55106-9)

Active ingredient

Hydrogen peroxide 1.4%

Other Information (Other information)
  • keep away from heat or direct sunlight
  • Do not use if safey seal under cap is broken or missing

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.159510 · Updated: 2026-03-14T23:07:45.169331