Label: GILTUSS BUCALSEP- benzocaine, menthol, zinc chloride spray

  • NDC Code(s): 58552-135-01
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL)

    Benzocaine, 6.5% (1950 mg)

    Zinc Chloride, 0.12% (36 mg)

    Menthol, 0.1% (30 mg)

  • PURPOSE

    Purposes

    Anesthetic

    Astringent

    Anesthetic

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:

    • Spray Giltuss Bucalsep several times to affected areas in the mouth or lips or as directed by a doctor or dentist
    • use as a gargle or mouthwash
    • gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
    • use up to 4 times daily or as directed by a doctor or dentist
    • Children under 12 years of age:should be supervised in the use of this product

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

  • STORAGE AND HANDLING

    Other information

    • Tamper evident:Do not use if safety seal is broken or missing
    • Store at room temperature
  • QUESTIONS

    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 INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

    giltuss.com

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums
  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    Oral Spray

    Giltuss BUCALSEP®

    SORE THROAT AND ORAL INFECTIONS

    ALCOHOL FREE. SUGAR FREE. DYE FREE

    RELIEVES

    • SORE THROAT
    • THROAT INFECTION
    • CANKER SORES
    • OTHER ORAL PAINS AND INJURIES

    SPEARMINT FLAVOR

    1FL OZ (30 mL)

    58552-135 Bucalsep

  • INGREDIENTS AND APPEARANCE
    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)
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