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FDA LABEL GENERIC: Benzocaine MFR: Syka Pharma Inc.

Benzocaine 5 % Mouthwash

Benzocaine 5%

Oral Pain Reliever

INDICATIONS AND USAGE

For the temporary relief of minor irritation, pain, sore mouth, and sore throat.

WARNINGS

If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentists or doctor promptly.

Do not exceed recommended dosage.

Do not use

this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics.

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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) rapid heart rate dizziness or lightheadedness headache shortness of breath atigue or lack of energy

DOSAGE AND ADMINISTRATION

Shake well upside down. Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out. Children under 12 years of age should be supervised in the use of the product. Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Do not use for teething. Children under 2 years of age: Do not use.

store at 68-77 ° F (20-25 ° C)

Purified water, Vegetable glycerin, PEG 400, Sorbitol, Polysorbate 80, Natural orange flavor, Potassium sorbate, Xanthan gum, Citric acid, Beta-carotene.

Package Labeling: