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.
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Otc - Active Ingredient
Active ingredientBenzocaine 10%
Otc - Purpose
PurposeOral Pain Reliever
Indications & Usage
Usefor the temporary relief of pain due to toothaches
- WarningsMethemoglobinemia 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)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energyAllergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics
Otc - Do Not Use
- Do not usemore than directedfor more than 7 days unless told to do so by a dentist or doctorfor teethingin children under 2 years of age
Otc - Stop Use
- Stop use and ask a doctor if
- Swelling, rash or fever developsirritation, pain or redness persists or worsenssymptoms do not improve in 7 daysallergic reaction occurs
Otc - 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.
Dosage & Administration
- DirectionsCarefully remove gel cushion from blister. Gently mold iwth fingers until soft. Apply to affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth.Adults and children 12 years of age and older: use up to 3 times daily or as directed by dentist or doctor.
- Children under 12 years of age: ask a dentist or doctorChildren under 2 years of age: do not use
Storage And Handling
Other informationDo not use if blister card is broken. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. These toothache cushions are designed to completely dissolve in place.Store at room temperature 15-30°C (59-86°F)
Inactive ingredientsCellulose Gum, Flavor, Menthol, Polyethylene Glycol
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