Indications and uses
Uses temporary relieves pain due to the following mouth and gum irritations sore mouth and throat canker sores minor dental procedures dentures or orthodontic appliance
Uses temporary relieves pain due to the following mouth and gum irritations sore mouth and throat canker sores minor dental procedures dentures or orthodontic appliance
Directions: Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use
Active ingredients Purpose
Benzocaine, 6.5% ----------------- Anesthesic
Menthol, 0.1% ----------------------- Anesthesic
Zinc Chloride 0.12% --------------- Astringent
Uses
temporary relieves pain due to the following mouth and gum irritations
Warnings
Do not use
Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but 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.Stopo use and seek immediate medical attention if you or a child in your care develops:
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetic
Do not use
When using this product
Stop use and ask a doctor if
If pregnant or breastfeeding, ask a health professional before use
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away
Directions:
Adults and children 2 years of age and older
Children under 2 years of age: do not use
Other information
Store at room temperature
Inactive ingredients
Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose.
Questions or Comments?
Questions or comments?
Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST
Call your doctor for medical advice in the event of side effects.
Indication and usage section
Adults and children 2 years of age and older
apply to affected area
gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
use 4 times daily or as directed by dentist or doctor
children under 12 years of age should be supervised in the use of the product
Children under 2 years of age: do not use
NDC: 58552-135-01
Alcohol free
Oral Spray
Giltuss Bucalsep
Sore, Throat, Oral astringent
1 floz (30 mL)
Alcohol free, sugar free, dye free
Spearmint flavor
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-015-01 | Giltuss Bucalsep | 1 in 1 CARTON | SPRAY | 1 | 1 | |
| 65852-015-01 | Giltuss Bucalsep | 30 mL in 1 BOTTLE, PLASTIC | SPRAY | 30 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65852-015 | 65852-015-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC CATION | 13S1S8SF37 | ACTIB |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| CETYLPYRIDINIUM CHLORIDE | D9OM4SK49P | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Dextrum Laboratories Inc. | 3fa233dc-156c-1e95-e063-6294a90a8bbd | 2025-09-25 | Warnings | 65852-015-01 65852-015 65852001501 3fa233dc-156d-1e95-e063-6294a90a8bbd 3fa233dc-156c-1e95-e063-6294a90a8bbd |
Adverse event summaries are temporarily unavailable. Other product information remains available.