Composition:
Each 1g oral gel contains 200mg Benzocaine (20%w/w).
Indications:
For the temporary relief of occasional minor irritation and pain associated with:
• canker sores.
• sore mouth and throat.
• minor injury of the mouth and gums.
• minor dental procedures.
• minor irritation of the mouth and gums caused by dentures or orthodontic appliances.
Dosage and administration:
- Do not eat or drink for at least 1 hour after using and wash your hands before and after use.and keep out of your eyes
Adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a 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.
Side effects:
- Allergic reaction, like rash,hives, itching, swollen,blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking (unusual hoarseness) or swelling of the mouth, face, lips, tongue, or throat.
- Rarely it may occurs signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal,seizures, dizziness and headache,feeling tired or weak or shortness of breath.
Contraindication:
- Hypersensivity to Benzocaine or any of excipients
- People who have glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Heart problems, or lung problems
• for teething
-in children under 2 years of age
-for more than 7 days unless directed by a physician.
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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
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. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
Pregnancy:
Benzotics topical has been assigned to pregnancy category C. Benzotics topical is only recommended for use during pregnancy when benefit outweighs risk.
Lactation:
There are no data on the excretion of benzocaine topical into human milk.
Missed Dose:
1- Use a missed dose as soon as you think about it.
2- If it is close to the time for your next dose, skip the missed dose and go back to your normal Time, Do not use 2 doses at the same time or extra doses.