PREVENTION MOUTH SORE RINSE- hydrogen peroxide liquid

Prevention Mouth Sore Rinse by

Drug Labeling and Warnings

Prevention Mouth Sore Rinse by is a Otc medication manufactured, distributed, or labeled by Prevention Health Sciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hydrogen peroxide 1.4%

PURPOSE

Purpose

Oral debriding agent / Oral wound cleanser

INDICATIONS & 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.

Warnings

DO NOT USE

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

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

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

QUESTIONS

Questions? call (800) 473-1205

SPL UNCLASSIFIED SECTION

Formulated and Distribured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

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

INGREDIENTS AND APPEARANCE

PREVENTION MOUTH SORE RINSE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69951-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC CHLORIDE (UNII: 86Q357L16B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69951-004-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/01/2023

Labeler - Prevention Health Sciences, Inc. (968930540)