Active Ingredient
Benzocaine 20%
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Benzocaine 20% (NDC 0121-1077). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop using and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzocaine 20%
Oral Anesthetic
for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a 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 a child in your care develops:
Allergy alert: Do not use if you have a 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 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
| adults and children 2 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 them spit out. Use up to 4 times daily or as directed by a dentist or doctor. |
| children under 12 years of age | should be supervised in the use of the product |
| children under 2 years of age | do not use |
flavor, polyethylene glycol, sucralose
call 1-800-845-8210
*This product is not manufactured or distributed by Beutlich Pharmaceuticals. LLC, the distributor of HurriCaine ONE®, and owner of the registered trademark HurriCaine ONE®, [Beutich Pharmaceuticals, LLC does not make or license PAI's product.]
NDC 0121-1077-01
BENZOCAINE 20% SOLUTION
Individually Wrapped Single-Unit Dose Applicator
20% Benzocaine Oral Anesthetic
CHERRY FLAVOR
Store at 15° - 30°C (59 - 86°F)
Warnings
METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia
a rare but serious condition that must be treated promptly because it reduces the amount of
oxygen 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 a history of allergy to local anesthetics such as
procaine, butacaine, benzocaine, or other "caine" anesthetics.
Please refer to Drug Facts for complete product information.
1 Single-Unit Dose Applicator 0.017 fl oz (0.5 mL)
NDC 0121-1077-25
PAI Pharma Compare to the active ingredient in HurriCaine ONE®
BENZOCAINE 20%
SOLUTION
Individually Wrapped Single-Unit Dose Applicator
20% Benzocaine Oral Anesthetic
CHERRY FLAVOR
25 Single-Unit Dose Applicators
0.017 fl. oz. (0.5 mL) EACH
0.425 fl. oz (12.5 mL) TOTAL
* Please review the disclaimer below.