View Drug - Gumsol
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Gumsol

Generic: BENZOCAINE, ZINC CHLORIDE

100%
Basic Information
Manufacturer
Kramer Novis
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf
Purpose
Purposes Anesthetic Astringent
Indications & Usage
Use Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances.
Warnings
Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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.

Stop 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.

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly Do not use (unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething.

Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days • irritation, pain or redness persist or worsen • swelling, rash or fever develops.

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

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.