Antipyrine and Benzocaine Otic

Acella Pharmaceuticals

Antipyrine and Benzocaine Otic Solution, USP Rx Only

FULL PRESCRIBING INFORMATION

DESCRIPTION: Each mL contains:

Antipyrine..........54  mg  (5.4%)

Benzocaine..........14.0 mg (1.4%)

(also contains glycerin and oxyquinoline sulfate)

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 0C (32F) but returns to normal consistency, unchanged at room temperature.

Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phyl-3-pyrazolin-5-one. 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 ingredients are represented by the following structural formula

Antipyrine and Benzocaine Otic Solution comibine the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and 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

Uses

Indications and Usage: 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, epecially 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: Antipyrine and Benzocaine Otic Solution is contraindicated in any person with hypersensitivity to any of the components or substances related tot hem. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.

Warnings: FOR USE IN EARS ONLY NOT FOR USE IN EYES

KEEP OUT OF REACH OF CHILDREN

Discontinue promptly if sensitization or irritation occurs.

Precautions: Information for Patients: Avoid contaminating the dropper tip with material from the ear fingers or other source.

CARCONOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: No long-term studies in animals or humans have been conducted.

PREGNANCY CATEGORY 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 AND ADMINISTRATION: ACUTE OTITIS MEDIA: Instill Antipyrine and Benzocaine Otic Soution permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine Benzocaine Otic Solution and insert into the meatus. Repeat every one to two hours until pain an congestion are relieved.

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

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

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

Note: After use, do not rinse dropper tip, replace cap and close tightly

Protect solution from light and heat, and do not use if it is brown or contains a precipitate.

DISCARD THIS PRODUCT 6 MONTHS AFTER OPENING.

How Supplied: Antipyrine and Benzocaine Otic Solution is supplied in a 10 mL plastic botle with a dropper tip under cap (NDC 42192-708-10) and a 15 mL bottle with a dropper tip under cap (NDC 42192-710-15). Store at 20-25C (68-77F); excursions permitted to 1530C  (59-86F) see USP Controlled Room Temperature).

Manufactured for: Acella Pharmaceuticals, LLC

9005 Westside Parkway, Alpharetta, GA 30009

1-800-541-4802

Usual Dosage: See package insert for complete information.

Storage: Store at 20-25C (68-77F); excursions permitted to 1530C  (59-86F) see USP Controlled Room Temperature). Protect from light and heat.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Manufactured for:

Acella Pharmaceuticals, LLC

Alpharetta, VA30009