FDA Label for Oral Pain Relief
View Indications, Usage & Precautions
Oral Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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" anesthetics. If a skin reaction occurs, stop use and seek medical help right away.
Active Ingredient
Benzocaine 20%
Purpose
Oral anesthetic
Uses
temporary relieves pain associated with the following mouth
and gum irritations: • toothache • sore gums • canker
sores • braces • minor dental procedures • dentures
Do Not Use
• for teething
• in children under 2 years of age
• more than recommended
• for more than 7 days unless told to do so by a dentist or doctor
When Using This Product
• avoid contact with the eyes
Stop Use And Ask A Doctor If
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling, rash or fever develops
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.
Directions
• do not exceed recommended dosage
• do not use for more than 7 days unless told to do so by a dentist or doctor
• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist
• children between 2 and 12 years of age: adult supervision should be given in use of this product
• children under 2 years of age: do not use
Other Information
• do not use tube if it is cut prior to opening
• to open tube, cut open tip of tube on score mark with scissors
• store at a controlled room temperature 68°-77°F (20°-25°C)
Inactive Ingredients
Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid
Questions Or Comments?
1-800-540-3765
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