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

  • NDC Code(s): 65852-015-01
  • Packager: Dextrum Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 25, 2025

If you are a consumer or patient please visit this version.

  • 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

    • sore mouth and throat
    • canker sores
    • minor dental procedures
    • dentures or orthodontic appliance

    Uses

  • Warnings

    Allergy 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

    Warnings

  • 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

    Do not use

  • 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

    When using this product

  • 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

    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

    • 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

    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

  • PRINCIPAL DISPLAY PANEL

    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

  • INGREDIENTS AND APPEARANCE
    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)