menthol and benzocaine

FDA Drug Profile — Chloraspetic, CHLORASEPTIC

Drug Details

Generic Name
menthol and benzocaine
Brand Names
Chloraspetic, CHLORASEPTIC
Application Number
M022
Sponsor
Prestige Brands Holdings, Inc.
NDC Codes
3
Dosage Forms
LOZENGE
Routes
ORAL
Active Ingredients
BENZOCAINE, MENTHOL

Indications and Usage

Uses Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.

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 other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Sore Throat Warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by a doctor. Do not use for teething in children under 6 years of age When using this product do not exceed recommended dosage. Stop use and ask a dentist or doctor if: sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.