benzocaine, menthol, zinc chloride

FDA Drug Profile — Orajel Gum Pain 3X Medicated

Drug Details

Generic Name
benzocaine, menthol, zinc chloride
Brand Names
Orajel Gum Pain 3X Medicated
Application Number
M022
Sponsor
Church & Dwight Co., Inc.
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
BENZOCAINE, MENTHOL, UNSPECIFIED FORM, ZINC CHLORIDE

Indications and Usage

Uses for the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums

Warnings

Warnings Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists this product for more than 7 days unless directed by a doctor or a dentist Ask a doctor or pharmacist before use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics When using this product, do not exceed recommended dosage Stop use and ask a doctor or dentist if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting symptoms do not improve in 7 days irritation, pain or redness persists or increases, or a rash appears on the skin If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.