ANTIPYRINE AND BENZOCAINE

DIRECT RX

ANTIPYRINE AND BENZOCAINE

FULL PRESCRIBING INFORMATION: CONTENTS*

• ANTIPYRINE AND BENZOCAINE DESCRIPTION SECTION
• CLINICAL PHARMACOLOGY SECTION
• INDICATIONS & USAGE SECTION
• ANTIPYRINE AND BENZOCAINE CONTRAINDICATIONS SECTION
• WARNINGS SECTION
• PRECAUTIONS SECTION
• DOSAGE & ADMINISTRATION SECTION
• HOW SUPPLIED SECTION
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

DESCRIPTION SECTION

Antipyrine and Benzocaine Otic Solution is an otic solution containing Antipyrine, Benzocaine, Oxyquinoline Sulfate, and Anhydrous Glycerin for use in the ear. The solution congeals at 0°C (32°F), but returns to normal consistency, unchanged, at room temperature.

Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5- one. The active ingredient is represented by the structural formula:

Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol.

Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate or Benzoic acid, 4-amino-, ethyl ester. The active ingredient is represented by the structural formula:

It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.

EACH mL CONTAINS:

Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate.

CLINICAL PHARMACOLOGY SECTION

Antipyrine and Benzocaine Otic Solution combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and to alleviate pain and discomfort in acute otitis media.

Antipyrine and Benzocaine Otic Solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

INDICATIONS & USAGE SECTION

Acute Otitis media of various etiologies-prompt relief of pain and reduction of inflammation in the congestive and serous stages.-adjuvant therapy during systemic antibiotic administration for resolution of the infection.

Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults.

Removal of Cerumen-facilitates the removal of excessive or impacted cerumen

CONTRAINDICATIONS SECTION

The product is contraindicated in any person with hypersensitivity to any of the components or substances related to them.

This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.

WARNINGS SECTION

FOR USE IN EARS ONLY-NOT FOR USE IN EYES

Discontinue promptly if sensitization or irritation occurs

PRECAUTIONS SECTION

Information for Patients

Avoid contaminating the dropper with material from the ear, fingers or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term studies have been conducted.

PregnancyCategory C

Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution. It is also not known whether Antipyrine and Benzocaine Otic Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Antipyrine and Benzocaine Otic Solution is administered to a nursing woman.

DOSAGE & ADMINISTRATION SECTION

Acute otitis media

Instill Antipyrine and Benzocaine Otic Solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

Removal of Cerumen

Before: Instill Antipyrine and Benzocaine Otic Solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.

After: Antipyrine and Benzocaine Otic Solution is useful for drying out the ear canal or relieving discomfort.

Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following instillation.

HOW SUPPLIED SECTION

Antipyrine and Benzocaine Otic Solution is supplied in a plastic light-resistant dropper-bottle with a screwtop cap containing 10 mL (NDC# 76439-305-10) and 15 mL (NDC# 76439-305-15). Tamper evident seal is on the bottle cap. Do not use if seal is broken.

Storage and Handling

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing.

Call your doctor for medical advice about side effects. You may report side effects to 813-283-1344.

Manufactured for:

Virtus Pharmaceuticals, LLC

Tampa, FL 33619

Rev. 04/12

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

VIRTUS

PHARMACEUTICALS

NDC 76439-305-10

Antipyrine &

Benzocaine

Otic Solution, USP

Each mL Contains the Active Ingredients:

Antipyrine USP            54 mg

Benzocaine USP        14 mg

Rx only

10 mL (1/3 fl. oz.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL