DOSAGE & ADMINISTRATION SECTION.

Directions. Read Directions on side panel for how to useadults and children years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and then spit out. Use up to times daily or as directed by dentist or doctor.children under 12 years of ageshould be supervised in the use of the productchildren under years of agedo not use. Read Directions on side panel for how to use.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. flavor, polyethylene glycol, sucralose.

INDICATIONS & USAGE SECTION.

Uses. for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

OTC - ACTIVE INGREDIENT SECTION.

Active Ingredient. Benzocaine 20%.

OTC - DO NOT USE SECTION.

Do not use. for teethingin children under years of age. for teething. in children under years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. If more than used for pain is accidently swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.

OTC - PURPOSE SECTION.

Purpose. Oral Anesthetic.

OTC - QUESTIONS SECTION.

Questions or comments. call 1-800-845-8210This product is not manufactured or distributed by Beutlich Pharmaceuticals. LLC, the distributor of HurriCaine ONE(R), and owner of the registered trademark HurriCaine ONE(R), [Beutlich Pharmaceuticals, LLC does not make or license PAIs product.].

OTC - STOP USE SECTION.

Stop using and ask doctor if. sore mouth symptoms do not improve in daysirritation, pain, or redness persists or worsensswelling, rash, or fever develops. sore mouth symptoms do not improve in days. irritation, pain, or redness persists or worsens. swelling, rash, or fever develops.

OTC - WHEN USING SECTION.

When using this product. avoid contact with eyesdo not exceed recommended dosagedo not use for more than days unless directed by doctor or dentist. avoid contact with eyes. do not exceed recommended dosage. do not use for more than days unless directed by doctor or dentist.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel pouch. NDC 0121-1077-01BENZOCAINE 20% SOLUTIONIndividually Wrapped Single-Unit Dose Applicator20% Benzocaine Oral AnestheticCHERRY FLAVORStore at 15 30C (59 86F)WarningsMETHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemiaa rare but serious condition that must be treated promptly because it reduces the amount ofoxygen carried in the blood. This can occur even if you have used this product before. stop use and seek immediate medical attention if you or your child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert: Do not use this product if you have history of allergy to local anesthetics such asprocaine, butacaine, benzocaine, or other caine anesthetics. Please refer to Drug Facts for complete product information. Single-Unit Dose Applicator 0.017 fl oz (0.5 mL). Benzocaine pouch.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other information. do not use if foil pouch is torn or openstore at 15-30C (59-86F). do not use if foil pouch is torn or open. store at 15-30C (59-86F).

WARNINGS SECTION.

Warnings. METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, rare but 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:pale, gray, or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energy Allergy 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 if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.. pale, gray, or blue colored skin (cyanosis). headache. rapid heart rate. shortness of breath. dizziness or lightheadedness. fatigue or lack of energy Do not use. for teethingin children under years of age. for teething. in children under years of age. When using this product. avoid contact with eyesdo not exceed recommended dosagedo not use for more than days unless directed by doctor or dentist. avoid contact with eyes. do not exceed recommended dosage. do not use for more than days unless directed by doctor or dentist. Stop using and ask doctor if. sore mouth symptoms do not improve in daysirritation, pain, or redness persists or worsensswelling, rash, or fever develops. sore mouth symptoms do not improve in days. irritation, pain, or redness persists or worsens. swelling, rash, or fever develops. Keep out of reach of children. If more than used for pain is accidently swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.