DOSAGE & ADMINISTRATION SECTION.
Directions. Directionsdo not exceed recommended 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: do not use. do not exceed recommended dosage.
INULLCTIVE INGREDIENT SECTION.
Inactive ingredients. flavor, polyethylene glycol, sodium saccharin.
INDICATIONS & USAGE SECTION.
Uses. for 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 - ACTIVE INGREDIENT SECTION.
Active ingredient. Benzocaine 20%.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. 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.
Do not use. Do not useif imprinted seal under cap is broken or missingfor teethingin children under years of age. if imprinted seal under cap is broken or missing. for teething. in children under years of age.
OTC - WHEN USING SECTION.
When using this product. When using this product avoid contact with eyes.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0283-1886-31HURRICAINE(R)Topical Anesthetic LIQUID20% Benzocaine Oral AnestheticPINULL COLADAManufactured for:Beutlich(R) Pharmaceuticals, LLCBunnell, FL 32110Made in the USA1 fl. oz. 1oz carton image.
STORAGE AND HANDLING SECTION.
Other information. store at 20-25 (68-77 F) store at 20-25 (68-77 F).
Warnings. Methemoglobinemia warning:Use of this product may cause methemoglobinemia, serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or child in your care develops:o pale, gray, or blue colored skin (cyanosis)o headache rapid heart rateo shortness of breatho dizziness or lightheadednesso fatigue or lack of energyAllergy alert: Do not use if you have history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other caine anesthetics.Sore throat warning: if sore throat is severe, persists for more than days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult doctor promptly. If sore mouth symptoms do not improve in days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.