Antipyrine and Benzocaine

County Line Pharmaceuticals, LLC
County Line Pharmaceuticals, LLC

Antipyrine and Benzocaine Otic Solution USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• ANTIPYRINE AND BENZOCAINE DESCRIPTION:
• CLINICAL PHARMACOLOGY:
• ANTIPYRINE AND BENZOCAINE INDICATIONS AND USAGE:
• ANTIPYRINE AND BENZOCAINE CONTRAINDICATIONS:
• WARNINGS:
• PRECAUTIONS:
• ANTIPYRINE AND BENZOCAINE DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
  • Storage:
• PRINCIPAL DISPLAY PANEL - CARTON

FULL PRESCRIBING INFORMATION

FOR USE IN THE EARS ONLY

Topical Decongestant and Analgesic

Rx Only

DESCRIPTION:

Antipyrine and Benzocaine Otic Solution, USP is an otic solution containing Antipyrine, Benzocaine, and Anhydrous Glycerin for use in the ear.  The solution congeals at 0^o C (32^o 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:

C₁₁H₁₂N₂O

MW=188.23

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:

C₉H₁₁NO₂

MW=165.19

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:  Glycerin (anhydrous)

CLINICAL PHARMACOLOGY:

Antipyrine and Benzocaine Otic Solution, USP 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, USP 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 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.

Removal of Cerumen

• facilitates the removal of excessive or impacted cerumen.
  

CONTRAINDICATIONS:

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:

FOR USE IN EARS ONLY - NOT FOR USE IN EYES

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS:

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.

Pregnancy:  Category C.  Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution, USP.  It is also not known whether Antipyrine and Benzocaine Otic Solution, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Antipyrine and Benzocaine Otic Solution, USP 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, USP is administered to a nursing woman.

DOSAGE AND ADMINISTRATION:

Acute otitis media:  Instill Antipyrine and Benzocaine Otic Solution, USP, 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, USP 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, USP 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, USP 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, USP should be inserted into the meatus following instillation.

HOW SUPPLIED:

Antipyrine and Benzocaine Otic Solution, USP is supplied in a 15 mL tight light-resistant bottle.  Tamper evident seal on bottle cap.  Do not use if seal is torn, broken or missing.

15 mL bottle      NDC# 43199-016-15

Storage:

Store at 20^o-25^oC (68^o-77^oF) [see USP Controlled Room Temperature].  Protect from heat and light.  Protect from freezing.  Keep tightly closed.

Manufactured for:

County Line Pharmaceuticals, LLC

Brookfield, WI  53005

1-866-207-5636

Rev. 10/11

PRINCIPAL DISPLAY PANEL - CARTON

NDC# 43199-016-15

Antipyrine and

Benzocaine Otic

Solution USP

Each mL Contains the Active Ingredients:

Antipyrine USP 54 mg

Benzocaine USP 14 mg

Rx Only

county line pharmaceuticals, llc

15 mL (1/2 fl. oz.)