Otc - Active Ingredient
Benzocaine 10% . . . Oral pain reliever
Menthol 0.25% . . . Oral pain reliever
Toothache And Gum Relief Cushions Dressing
FDA Label NDC 11822-1616
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Toothache And Gum Relief Cushions (NDC 11822-1616). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
for the temporary relief of pain due to toothaches
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 develop: * 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" anesthetics
Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * iffitation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic 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
carefully remove gel cushion from blister. Gently mold with fingers until soft. Apply to the 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 a dentist or doctor. Children under 12 years of age: ask a dentist or doctor. Children under 2 years of age: do not use
Other Safety Information
Do 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 Ingredient
cellulose gum, flavor, polyethylene glycol
* Please review the disclaimer below.
