Dosage and administration
Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Store at 59°-86°F (15°-30°C). Protect from freezing.
Benzocaine 200mg (in each g)
Oral Anesthetic
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
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 the 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
When using this product Avoid contact with eyes. If contact occurs, flush with water.
Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.
Keep out of reach of children.
Store at 59°-86°F (15°-30°C). Protect from freezing.
flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68400-509-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9a7b-d83d-e063-dadaa90ab31f | d7c6af67-d058-3e88-e053-2a95a90a83e0 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68400-509-30 | Quala Topical Anesthetic Gel | 30 g in 1 JAR | GEL | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68400-509 | QUALA TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] | 1 | Legacy NDC, 1 package rows | 20220212_d7c6af67-d058-3e88-e053-2a95a90a83e0.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68400-509 | 68400-509-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C RED NO. 3 | PN2ZH5LOQY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| D&C GREEN NO. 5 | 8J6RDU8L9X | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| d7c6b892-9e3a-347e-e053-2995a90a9800 | d7c6af67-d058-3e88-e053-2a95a90a83e0 | 2022-02-03 | Warnings | d7c6b892-9e3a-347e-e053-2995a90a9800 d7c6af67-d058-3e88-e053-2a95a90a83e0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.