for temporary relief of occasional minor irritation and pain associated with: 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
Directions do not exceed recommended dosage adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then 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
Benzocaine 20%
Oral Anesthetic
for temporary relief of occasional minor irritation and pain associated with:
Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a 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:
• 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 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 irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
Do not use
When using this product avoid contact with eyes
Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Directions
adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then 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
store at 20°-25°C (68°-77°F)
flavor, polyethylene glycol, sodium saccharin
1-800-238-8542
M-F: 8:00 a.m. - 4:30 p.m. ET
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0283-0569-31 | ML - Milliliter | 0283-0569 | 1326f189-9c69-460f-a071-c36eae179397 | 1 | 2012-07-24 |
| 0283-0569-72 | EA - Each | 0283-0569 | 0e9c6d99-ad67-4acf-8ed5-6b7b6f579675 | 1 | 2016-09-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65734-501 | 65734-501-01, 65734-501-72 |
| 0283-0569 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HurriCaine Topical Anesthetic Liquid | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fee9969d-ad1a-4f44-9741-a0a44c9e1128 | 2025-11-06 | Warnings | 0283-0569 |
| c22ae374-a472-d090-e053-2a95a90a70e8 | c22ae374-a471-d090-e053-2a95a90a70e8 | 2021-05-14 | Warnings | c22ae374-a472-d090-e053-2a95a90a70e8 c22ae374-a471-d090-e053-2a95a90a70e8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.