OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients Purpose |
Benzocaine 20%....................................................................Oral pain reliever |
Drug Facts
Active ingredients Purpose |
Benzocaine 20%....................................................................Oral pain reliever |
Uses
Warnings
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:
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.
Do not use:
When using this product:
Stop use and ask doctor if
Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions:
adults and children 2 years of age and over | apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
children under 12 years of age | adult supervision should be given in the use of this product |
children under 2 years of age | do not use |
Other information
Inactive Ingredients
benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid
MAXIMUM STRENGTH
ORAL PAIN RELIEF GEL
FAST ACTING
Benzocaine 20% pain relieving gel
NET WT 0.5 OZ (14g)
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73492-717-50 | Oral pain relief | 1 in 1 CARTON | GEL | 1 | 3 | |
| 73492-717-50 | Oral pain relief | 14 g in 1 TUBE | GEL | 14 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73492-717 | 73492-717-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Oral pain relief | BENZOCAINE | ALAINA HEALTHCARE PRIVATE LIMITED | d98c1b2f-fe75-4d52-b082-1abb7628c59e | 2025-12-09 | Warnings | 73492-717-50 73492-717 73492071750 4584247f-6422-216f-e063-6294a90a0d80 d98c1b2f-fe75-4d52-b082-1abb7628c59e |
Adverse event summaries are temporarily unavailable. Other product information remains available.