The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
- For the temporary relief of occasional minor irritation and pain, associated with:canker soressore mouth and throatminor injury of the mouth and gumsminor dental proceduresminor irritation of the mouth and gums caused by dentures or orthodontic appliances
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)
• 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.
Do Not Use
- Do not use:if the tray seal is broken or missingif cap is missing or damagedfor teethingin children under 2 years of age
When Using This Product
Keep Out Of Reach Of Children.
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
- Directions:Do not exceed recommended dosage.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 productchildren under 2 years of age: do not use
- Store at 20°-25° C (68°-77° F)
- Flavor, polyethylene glycol, sodium saccharin
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