PREVENTION MOUTH RINSE- hydrogen peroxide liquid

Prevention Mouth Rinse by

Drug Labeling and Warnings

Prevention Mouth 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 1.5%

PURPOSE

Purpose

Oral debriding agent / Antiseptic

INDICATIONS & USAGE

Uses

• first aid to help reduce the risk of infection in minor cuts and scrapes caused by
• dentures
• dental procedures
• orthodontic appliances
• accidental injury
• aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth
• for temporary use to cleanse canker sores, minor wounds and gum irritation

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 years of age should be supervised in the use of product.
• children under 2 years of age: consult a dentist or doctor.

STORAGE AND HANDLING

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 water, glycerin, poloxamer 407, sodium lauryl sulfate, disodium EDTA, Mentha piperita (peppermint) oil, sodium citrate, sodium saccharin, citric acid, zinc chloride, menthol

SPL UNCLASSIFIED SECTION

Questions? (800) 473-1205

Manufactured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

PREVENTION™ MOUTH RINSE

Formulated for MOUTH SORE RELIEF

Oral Antiseptic for Healing of 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 RINSE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69951-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69951-002-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/29/2019

Labeler - Prevention Health Sciences, Inc. (968930540)

Establishment
Name	Address	ID/FEI	Business Operations
Prevention Health Sciences, Inc.		968930540	manufacture(69951-002)