Storage and handling
Other information store at room temperature 20° to 25°C (68° to 77°F) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted do not use continuously
Other information store at room temperature 20° to 25°C (68° to 77°F) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted do not use continuously
Active ingredient 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 your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
Stop use and ask a doctor if
If pregnant or breast-feeding , ask a health professional before use.
Keep out of reach of children. In cases of overdose, get medical help or contact a Poison Control Center right away.
Adults and children 2 years of age and older. | Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around 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. | Do not use. |
Other information
Inactive ingredients
glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63868-477-11 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b92b-a426-e053-dadaa90af4c2 | QC Maximum Strength Oral Analgesic 0.42oz 95362 (2019) - ZDP |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-477-11 | Quality Choice Maximum Strength Oral Pain Relieving | 11.9 g in 1 TUBE | GEL | 11.9 | 1 | |
| 63868-477-11 | Quality Choice Maximum Strength Oral Pain Relieving | 1 in 1 CARTON | GEL | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63868-477 | 63868-477-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| PEPPERMINT OIL | AV092KU4JH | 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 |
|---|---|---|---|---|---|---|
| 8fb7f300-a2c0-efa1-e053-2a95a90a8723 | 8fb7d70c-3d6c-41a6-e053-2995a90a5138 | 2019-08-09 | Warnings | 8fb7f300-a2c0-efa1-e053-2a95a90a8723 8fb7d70c-3d6c-41a6-e053-2995a90a5138 |
Adverse event summaries are temporarily unavailable. Other product information remains available.