Active Ingredients And Purpose
Active Ingredients
Benzocaine 200mg (in each g)
Purpose
Oral Anesthetic
Quala Topical Anesthetic Gel
- Manufacturer
- National Distribution & Contracting, Inc
- Effective date
- 2026-03-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:50:34
Key Label Information#
Uses
Use
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Warnings
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 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: pale, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy 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 for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age 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.
Directions And Dosage
Directions
Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Other Label Information
Other Information
Store at 59°-86°F (15°-30°C). Protect from freezing.
Inactive Ingredients
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.
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43128-028-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a77d-d83d-e063-dadaa90ab31f | 9f81ffa5-05fd-4eef-e053-2995a90aac3e |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43128-028-30 | Quala Topical Anesthetic Gel | 30 g in 1 JAR | GEL | 30 | 3 |
Products#
- Quala Topical Anesthetic Gel
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43128-028 | 43128-028-30 |
Ingredients#
| 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 |
Complete SPL Sections#
Active Ingredients
Benzocaine 200mg (in each g)
Purpose
Oral Anesthetic
Use
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
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 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: pale, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy 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 for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age 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.
Directions
Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Other Information
Store at 59°-86°F (15°-30°C). Protect from freezing.
Inactive Ingredients
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.