Indications and uses
for the temporary relief of pain due to toothaches to help protect against infection of minor oral irritation
for the temporary relief of pain due to toothaches to help protect against infection of minor oral irritation
cut open tip of tubne on score mark adults and children 2 years of age and older; apply a small amount of product to the cavity and arround the gum surrounding the teeth 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 this product. Children under 2 years of age: ask a dentist or doctor.
Benzocaine 20.0% ..................................Oral pain reliever
Menthol 0.25% .......................................Oral pain reliever
Benzalkonium Chloride 0.1% ....................Antiseptic
for the temporary relief of pain due to toothaches
to help protect against infection of minor oral irritation
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
When using this product
Stop use and ask a doctor if
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Children under 2 years of age: ask a dentist or doctor.
Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin
Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
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 this product.
Children under 2 years of age: ask a dentist or doctor.
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 30142-354-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cc37-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 30142-354-02 | KrogerMaximum Strength | 9.3 g in 1 TUBE | CREAM | 9.3 | 1 | |
| 30142-354-09 | KrogerMaximum Strength | 1 in 1 CARTON | CREAM | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 30142-354 | 30142-354-02, 30142-354-09 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| PECTIN | 89NA02M4RX | IACT |
| Carboxymethylcellulose Sodium | K679OBS311 | 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 |
|---|---|---|---|---|---|---|
| 0252f7bc-2e61-412d-877c-0413feea660f | d6340d05-d0cb-491e-ab4e-d7669a613e78 | 2016-07-29 | Warnings | 0252f7bc-2e61-412d-877c-0413feea660f d6340d05-d0cb-491e-ab4e-d7669a613e78 |
Adverse event summaries are temporarily unavailable. Other product information remains available.