DESCRIPTION

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

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


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Antipyrine occurs together colorless crystals or white powder, has a contempt bitter taste and also is soluble in water and also alcohol.

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


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

EACH mL CONTAINS:

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


CLINICAL PHARMACOLOGY

Antipyrine and also Benzocaine Otic systems combines the hygroscopic residential property of anhydrous glycerin v the analgesic activity of antipyrine and also benzocaine to relieve pressure, alleviate inflammation and also congestion, and to reduce pain and discomfort in acute otitis media.

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


INDICATIONS and USAGE

Acute Otitis media of miscellaneous etiologies

-prompt relief that pain and reduction the inflammation in the congestive and also serous stages.

-adjuvant therapy throughout systemic antibiotic management for resolution the the infection.

Because that the near anatomical connection of the eustachian pipe to the sleep cavity, otitis media is a constant problem, particularly in youngsters in whom the tube is shorter, wider, and an ext horizontal than in adults.

Removal that Cerumen

-facilitates the removed of excessive or affected cerumen.


CONTRAINDICATIONS

The product is contraindicated in any type of person with hypersensitivity to any type of of the components or substances concerned them. This product is contraindicated in the existence of voluntary perforation the the tympanic membrane or discharge.


WARNINGS

FOR usage IN ears ONLY-NOT FOR use IN EYES

Discontinue promptly if sensitization or wake up occurs.


PRECAUTIONS

Information for Patients: protect against contaminating the dropper with material from the ear, finger or various other source.


Pregnancy

Pregnancy: classification C. Animal reproduction studies have actually not been conducted with Antipyrine and Benzocaine Otic Solution. It is likewise not recognized whether Antipyrine and also Benzocaine Otic systems can cause fetal damage when administered come a pregnant mrs or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution need to be offered to a pregnant woman just if clearly needed.


Nursing mothers

It is not recognized whether this medicine is excreted in human being milk. Since many drugs space excreted in human being milk, caution have to be exercised when Antipyrine and also Benzocaine Otic systems is administered to a education woman.


DOSAGE AND administration

Acute otitis media: Instill Antipyrine and Benzocaine Otic Solution, permitting the equipment to run along the wall of the ear canal until it is filled. Avoid emotional the ear with dropper. Climate moisten a noodle pledget with Antipyrine and also Benzocaine Otic Solution and also insert right into meatus. Repeat every one come two hrs until pain and also congestion room relieved.

Removal of Cerumen:

Before: Instill Antipyrine and Benzocaine Otic solution three times day-to-day for two or 3 days to aid detach cerumen from wall surface of ear canal and facilitate removal.

After: Antipyrine and Benzocaine Otic solution is helpful for dry out the ear canal or relieving discomfort.

Before and also after removed of cerumen, a noodle pledget moistened with Antipyrine and also Benzocaine Otic Solution have to be placed into the meatus complying with instillation.


HOW supplied

Antipyrine and Benzocaine Otic equipment NDC 21695-216-15 is offered in a 15 mL light-resistant dropper-bottle v a screwtop party cap. Tamper evident seal on party cap. Perform not usage if seal is broken.


Storage and Handling

Store at 20°-25°C (68°-77°F) . Safeguard from heat and also light. Safeguard from freezing.

Call your physician for clinical advice about side effects. You may report side results to the FDA in ~ 1-800-FDA-1088.

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Manufactured for:

Boca Pharmacal, Inc.

Coral Springs, FL 33065

www.bocapharmacal.com

1-800-354-8460

Rev. 04/09

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320


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