GILTUSS BUCALSEP- benzocaine, menthol, zinc chloride spray

Giltuss Bucalsep by

Drug Labeling and Warnings

Giltuss Bucalsep by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active ingredients Purpose

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

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

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

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

Warnings

Warnings

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

Do not use

Do not use

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

When using this product

When using this product

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

Stop use and ask a doctor if

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

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use

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

Directions

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

Other information

Other information

Store at room temperature

Inactive Ingredients

Inactive ingredients

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

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.

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

GILTUSS BUCALSEP 
benzocaine, menthol, zinc chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-015
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC CATION (UNII: 13S1S8SF37) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.12 mg  in 100 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6.5 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-015-01	1 in 1 CARTON	07/26/2018
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/26/2018

Labeler - Dextrum Laboratories Inc. (007392322)