Hydrogen Peroxide and Menthol

FDA Drug Profile — Orajel Antiseptic Rinse For All Mouth Sores

Drug Details

Generic Name
Hydrogen Peroxide and Menthol
Brand Names
Orajel Antiseptic Rinse For All Mouth Sores
Application Number
M022
Sponsor
Church & Dwight Co., Inc.
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
HYDROGEN PEROXIDE, MENTHOL, UNSPECIFIED FORM

Indications and Usage

first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures accidental injury orthodontic appliances canker sores dentures other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth

Warnings

When using this product do not swallow do not exceed recommended dosage Do not use this product for more than 7 days unless directed by a dentist or healthcare provider Stop use and see your physician promptly if swallowing, rash or fever develops; irritation, pain or redness persists or worsens; sore mouth symptoms do not improve in 7 days 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