Indications and uses
For the temporary relief of pain associated with canker sores and minor dental procedures.
For the temporary relief of pain associated with canker sores and minor dental procedures.
Adults and children 12 years of age and older: Apply to the affected area. 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: Consult a dentist or doctor.
Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
Drug Facts
Benzocaine, 20%
Oral Anesthetic
For the temporary relief of pain associated with canker sores and minor dental procedures.
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 this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
Do not exceed recommended dosage.
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.
Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
FD&C Red # 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69638-060-32 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5692-a426-e053-dadaa90af4c2 | Scott's Select Topical Anesthetic Gel |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69638-060 | 69638-060-32 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| XYLITOL | VCQ006KQ1E | 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 |
|---|---|---|---|---|---|---|
| 8a3b8909-dd8f-4272-8bf8-88d16b253eb8 | 933f02a8-aaab-4e7e-945f-644c476ece78 | 2020-04-27 | Warnings | 8a3b8909-dd8f-4272-8bf8-88d16b253eb8 933f02a8-aaab-4e7e-945f-644c476ece78 |
Adverse event summaries are temporarily unavailable. Other product information remains available.