GILTUSS BUCALSEP- benzocaine, menthol, zinc chloride spray 
Gil Pharmaceutical Corp

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Giltuss Bucalsep

Drug Facts

Active ingredients (in each 30 mL)

Benzocaine, 6.5% (1950 mg)

Zinc Chloride, 0.12% (36 mg)

Menthol, 0.1% (30 mg)

Purposes

Anesthetic

Astringent

Anesthetic

Warnings

Do not use

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

Ask a doctor or pharmacist before use if you have

  • a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

When using this product, do not exceed recommended dosage

Stop use and ask a doctor or dentist if

  • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting
  • symptoms do not improve in 7 days
  • irritation, pain or redness persists or increases, or a rash appears on the skin

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older:

Children under 2 years of age:consult a dentist or doctor

Other information

Questions or Comments?

Call 1-800-848-9114, Mon. - Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

Inactive ingredients:Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

Uses

MAXIMUM STRENGTH

Oral Spray

Giltuss BUCALSEP®

SORE THROAT AND ORAL INFECTIONS

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

SPEARMINT FLAVOR

1FL OZ (30 mL)

58552-135 Bucalsep

GILTUSS BUCALSEP 
benzocaine, menthol, zinc chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-135
Route of AdministrationTOPICAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 mL
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SPEARMINT (UNII: J7I2T6IV1N)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Coloryellow (Light yellow) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-135-011 in 1 CARTON07/26/2018
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/26/2018
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58552-135)

Revised: 10/2023
Document Id: 08741352-8ee7-1603-e063-6394a90a93a1
Set id: 85053391-8d71-ab4f-e053-2991aa0a7e08
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp