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61010-8100-1,-2, Pain Relief


Active Ingredients

Benzocaine 20% (w/w)


Purpose

Oral pain reliever


Uses

temporarily relieves pain caused by

  • toothache
  • dental work
  • minor irritation or injury of the mouth and gums
  • canker sores
  • gum sores
  • cheek bites
  • denture irritation

Warnings

For oral use only.Avoid contact with eyes.


SPL UNCLASSIFIED SECTION

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 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

SPL UNCLASSIFIED SECTION

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.


Do not use

  • for teething
  • in children under 2 years of age

When using this product

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.


Directions

  • adults and children 2 years of age and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
  • children under 2 years of age: do not use

Other Information

  • Do not use if packet is torn, cut, or opened
  • Store at room temperature, 15º to 30ºC (59º to 86ºF)
  • Avoid contact with eyes

Inactive ingredients

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid