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FDA LABEL GENERIC: Benzocaine MFR: Pharmadel LLC

Benzocaine 20 % Oral Spray

Active ingredient and Purpose

.

Active ingredient Purpose
Benzocaine 20%...................... Oral pain reliever

INDICATIONS AND USAGE

For the temporary relief of

canker sores minor injury of the mouth and gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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 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.

Flammable. Keep away from fire or flame. Avoid smoking during application.

Do not use

more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age
sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops

If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

adults and children 2 years of age and older: apply product to a cotton swab or finger 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 product children under 2 years of age: do not use

Other information

do not use if clear seal over cap is torn, broken, or missing store between 68-77°F (20-25°C)

alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben

Questions or comments?

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist. by/ por:

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

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