OTC - PURPOSE SECTION.
Purpose. Oral Anesthetic.
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient. Benzocaine 20%.
OTC - QUESTIONS SECTION.
Questions or comments. 1-800-238-8542M-F: 8:00 a.m. to 4:30 p.m. ET.
OTC - WHEN USING SECTION.
When using this product. When using this product: avoid contact with eyes.
OTC - STOP USE SECTION.
Do not use. Do not useo if imprinted seal under cap is broken or missingo for teethingo in children under years of age.
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.
INDICATIONS & USAGE SECTION.
Uses. for thetemporary relief of occasional minor irritation and pain associated with:cankersoressore mouthand throatminorinjury of the mouth and gumsminordental proceduresminorirritation of the mouth and gums caused by dentures or orthodontic appliances. cankersores. sore mouthand throat. minorinjury of the mouth and gums. minordental procedures. minorirritation of the mouth and gums caused by dentures or orthodontic appliances.
DOSAGE & ADMINISTRATION SECTION.
Directions. Directionso do 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.
INULLCTIVE INGREDIENT SECTION.
Inactive ingredient. flavor, polyethylene glycol, sodium saccharin.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0283-0293-31HURRICAINETopical Anesthetic GEL20% Benzocaine Oral AnestheticWATERMELONManufactured for:Beutlich Pharmaceuticals LLCBunnell, FL 32110Made in the USA1 oz.. 1oz Watermelon Gel Carton image.
STORAGE AND HANDLING SECTION.
Other information. Other informationstore 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 headacheo 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.