Benzocaine, Menthol, Cetylpyridinium Chloride

FDA Drug Profile — Orasep

Drug Details

Generic Name
Benzocaine, Menthol, Cetylpyridinium Chloride
Brand Names
Orasep
Application Number
M022
Sponsor
Llorens Pharmaceutical International Division
NDC Codes
2
Dosage Forms
LIQUID
Routes
TOPICAL
Active Ingredients
BENZOCAINE, CETYLPYRIDINIUM CHLORIDE, MENTHOL

Indications and Usage

Uses for temporary relief of: Occasional minor sore throat pain and dry scratch throat. Pain due to canker sores. Pain due to minor irritation or injury of the mouth and gums. Pain due to minor dental procedures, minor irritations cause by dentures or orthodontic appliances.

Warnings

Warnings: Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics. Sore throat warning: If sore throat is sever, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitings, consult a doctor promptly. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens. Do not exceed recommended dosage. When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.