GILTUSS BUCALSEP- benzocaine, menthol, zinc chloride spray 
Dextrum Laboratories Inc.

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Giltuss Bucalsep

Active Ingredients

Active ingredients Purpose

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

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

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

Active ingredients

Uses

Uses

temporary relieves pain due to the following mouth and gum irritations

Uses

Warnings

Allergy alertWarnings

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

Warnings

Do not use

Do not use

Do not use

When using this product

When using this product

When using this product

Stop use and ask a doctor if

Stop use and ask a doctor if

Stop use and ask a doctor

Stop use and ask

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use

If pregnant

Keep out of reach of children

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 children

Directions

Directions:

Adults and children 2 years of age and older

Children under 2 years of age: do not use

Directions

Other information

Other information

Store at room temperature

Other Information

Inactive Ingredients

Inactive ingredients

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

Inactive ingredients

Questions or comments?

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.

Questions

Indication and 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 user

Active 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

GILTUSS BUCALSEP 
benzocaine, menthol, zinc chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-015
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC CATION (UNII: 13S1S8SF37) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.12 mg  in 100 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6.5 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65852-015-011 in 1 CARTON07/26/2018
130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/26/2018
Labeler - Dextrum Laboratories Inc. (007392322)

Revised: 9/2025
Document Id: 3fa233dc-156d-1e95-e063-6294a90a8bbd
Set id: 3fa233dc-156c-1e95-e063-6294a90a8bbd
Version: 1
Effective Time: 20250925
 
Dextrum Laboratories Inc.