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FDA LABEL GENERIC: Benzocaine MFR: Kramer Novis

Benzocaine 5 % / Zinc Chloride 0.1 % Mucosal Spray

Benzocaine (5%)

Zinc Chloride (0.1%)

Anesthetic

Astringent

INDICATIONS AND USAGE

Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries 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" anesthetic. If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: 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

Do not use (unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething.

Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days

irritation, pain or redness persist or worsen

swelling, rash or fever develops.

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and older Dry affected area with absorbent cotton.

Spray 4 times daily or as directed by physician.

Children under 12 years of age Should be supervised in the usage of this product.
Children under 2 years of age Do not use.

Phenylketonurics: Contains phenylalanine 2.5mg/mL.

• Store at controlled room temperature: 15°C-30°C (59°F-86°F)

• Tamper Evident: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.

Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).

Kramer Novis San Juan, PR 00917. Monday to Friday

(8am-4pm). 787-767-2072   www.kramernovis.com

Spray

Alcohol Free

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917

Packaging