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Generic: benzocaine, menthol, zinc chloride is used for the treatment of Bacterial Infections Burns Earache Fissure in Ano Hemorrhoids Herpes Simplex Otitis Externa Otitis Media Pain Pruritus Toothache Oral Ulcer Common Cold Skin Ulcer Wounds and Injuries Skin Diseases


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Drug Facts

Otc - Active Ingredient Section


Active ingredients (in each 30 mL)

Benzocaine, 6.5% (1950 mg)

Zinc Chloride, 0.12% (36 mg)

Menthol, 0.1% (30 mg)

Otc - Purpose Section


Purposes

Anesthetic

Astringent

Anesthetic

Warnings Section


Warnings

OTC - DO NOT USE SECTION


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

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION


When using this product, do not exceed recommended dosage

OTC - STOP USE SECTION


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

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Dosage & Administration Section


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 Section


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

Otc - Questions Section


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 Section


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

Indications & Usage Section


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

Package Label.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)



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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