Giltuss Bucalsep

Manufacturer
Dextrum Laboratories Inc.
Effective date
2025-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:35

Label at a glance#

ProductGiltuss Bucalsep
Active ingredientZINC CATION, BENZOCAINE, MENTHOL
Label structure14 sections

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Benzocaine, 6.5% ----------------- Anesthesic

Menthol, 0.1% ----------------------- Anesthesic

Zinc Chloride 0.12% --------------- Astringent

Active ingredientsActive ingredients

Uses

OTC - PURPOSE SECTION

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

UsesUses

Warnings

WARNINGS SECTION

Allergy alertAllergy alertWarnings

Do not use

  • IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists.
  • this product for more than 7 days unless directed by a doctor or a dentist

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:

  • 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetic

WarningsWarnings

Do not use

OTC - DO NOT USE SECTION

Do not use

  • for teething
  • in children under 2 years of age
  • for more than 7 days unless directed by a dentist or doctor

Do not useDo not use

When using this product

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • avoid contact with eyes. In case of eye contact, rinse with water

When using this productWhen using this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Sore throat is severe, persist for more than 2 days, is accompanied, or followed by fever, headache, rash,nausea or vomiting
  • Symptoms do not improve in 7 days
  • irritation, pain or redness persist or worsen
  • swelling, rash or fever develops

Stop use and ask a doctorStop use and ask a doctor

Stop use and askStop use and ask

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use

If pregnantIf pregnant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away

Keep out of reach of childrenKeep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

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

DirectionsDirections

Other information

OTHER SAFETY INFORMATION

Other information

Store at room temperature

Other InformationOther Information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose.

Inactive ingredientsInactive ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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.

QuestionsQuestions

Indication and usage section

INDICATIONS & USAGE SECTION

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

indication an userindication an user

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Active ingredientsActive ingredientsNDC: 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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-015-01Giltuss Bucalsep1 in 1 CARTONSPRAY11
65852-015-01Giltuss Bucalsep30 mL in 1 BOTTLE, PLASTICSPRAY301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-01565852-015-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEDextrum Laboratories Inc.3fa233dc-156c-1e95-e063-6294a90a8bbd2025-09-25WarningsExact identifier
ndc (package): 65852-015-01
ndc (product): 65852-015
ndc11 (package): 65852001501
spl id: 3fa233dc-156d-1e95-e063-6294a90a8bbd
spl set id: 3fa233dc-156c-1e95-e063-6294a90a8bbd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.