Storage and handling
Other information store at room temperature 20-25º (68-77ºF) 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 20-25º (68-77ºF) 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 blood. This can occur even I you have used this product before. Stop use and seek immediate medical attention if you are a child in your care develops:
Allergy Alert: do not use this product if you have a history of allergy to local anethetics as procaine, bucaine, 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 case of overdose or allergic reaction, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
| 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 ingredient glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
Distributed by CDMA, INC
Novi, MI 48375
Made in China
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-299-42 | Quality Choice | 1 in 1 CARTON | GEL | 1 | 4 | |
| 83324-299-42 | Quality Choice | 11.9 g in 1 TUBE | GEL | 11.9 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83324-299 | 83324-299-42 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-03-27 | full-release | 2026-06-01 00:58:00 |
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 |
|---|---|---|---|---|---|---|
| Quality Choice | BENZOCAINE | Chain Drug Marketing Association, Inc. | 24c3c4a3-bd76-198d-e063-6394a90ad45a | 2025-10-16 | Warnings | 83324-299-42 83324-299 83324029942 414fb186-8272-58da-e063-6394a90a7ac6 24c3c4a3-bd76-198d-e063-6394a90ad45a |
Adverse event summaries are temporarily unavailable. Other product information remains available.