OTC - ACTIVE INGREDIENT SECTION.
Active ingedient. Benzocaine 20%.
ADVERSE REACTIONS SECTION.
Adverse Reactions:. Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.
DOSAGE & ADMINISTRATION SECTION.
Directions. do not exceed recommend dosageadults and children years of age and older: apply to the affected area. Allow to remain in place at least minute and then spit out. Use up to times daily or as directed by dentist or doctor.children under 12 years of age: should be supervised in the use of the productchildren under years of age: consult dentist or doctor. do not exceed recommend dosage.
INULLCTIVE INGREDIENT SECTION.
Inactive ingredient. flavor, polyethylene glycol, sodium saccharin.
INDICATIONS & USAGE SECTION.
Uses. for the temporary relief of occasional minor irritation and pain, associated with:canker soressore mouth and throatminor injury of the mouth and gumsminor dental proceduresminor irritation of the mouth and gums caused by dentures or orthodontic appliances. canker sores. sore mouth and throat. minor injury of the mouth and gums. minor dental procedures. minor irritation of the mouth and gums caused by dentures or orthodontic appliances.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children.. If more than used for pain is accidentally swallowed, get medical help or contact Poison Control Center immediately.
OTC - PURPOSE SECTION.
Purpose. Oral Anesthetic.
OTC - QUESTIONS SECTION.
Questions or comments. 1-800-238-8542M-F: 8:00 a.m. 4:30 p.m. ET.
OTC - STOP USE SECTION.
Stop use and ask doctor if. sore throat is severe, persists for more than days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomitingsore mouth symptoms do not improve in days, or if irritation, pain, or redness persists or worsens. sore throat is severe, persists for more than days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting. sore mouth symptoms do not improve in days, or if irritation, pain, or redness persists or worsens.
OTC - WHEN USING SECTION.
When using this product. avoid contact with eyes. avoid contact with eyes.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0283-0998-31HURRICAINE(R)Topical Anesthetic GEL20% Benzocaine Oral AnestheticFRESH MINTManufactured for:Beutlich(R)Pharmaceuticals, LLCBunnell, FLwww.beutlich.com. 1oz gel carton image.
STORAGE AND HANDLING SECTION.
Other information. do not use if imprinted seal under cap is broken or missingstore at 20-25 (68-77 F). do not use if imprinted seal under cap is broken or missing. store at 20-25 (68-77 F).
Warnings. Allergy alert: Do not use if you have history of allergy to local anesthetics such as procaine, butaine, benzocaine or other caine anesthetics.