Menthol and Hydrogen Peroxide

FDA Drug Profile — Orajel 2x Gum Pain Alcohol-Free

Drug Details

Generic Name
Menthol and Hydrogen Peroxide
Brand Names
Orajel 2x Gum Pain Alcohol-Free
Application Number
M022
Sponsor
Church & Dwight Co., Inc.
NDC Codes
1
Dosage Forms
RINSE
Routes
ORAL
Active Ingredients
HYDROGEN PEROXIDE, MENTHOL, UNSPECIFIED FORM

Indications and Usage

Uses 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

Warnings Do not use this product for more than 7 days unless directed by a dentist or healthcare provider When using this product do not swallow do not exceed recommended dosage Stop use and see your physician promptly if swelling, 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