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Name:Antipyrine And Benzocaine
Manufacturer:County Line Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


ANTIPYRINE AND BENZOCAINE OTIC SOLUTION USP

ANTIPYRINE AND BENZOCAINE - antipyrine and benzocaine solution/ drops 
County line Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ANTIPYRINE AND BENZOCAINE
OTIC SOLUTION USP

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, 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:

Chemical Structure

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:

Chemical Structure

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: Glycerine (anhydrous), Oxyquinoline Sulfate.

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.

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

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 dropper-bottle with a screwtop bottle cap. Tamper evident seal on bottle cap. Do not use if seal is broken.

15 mL dropper-bottle          NDC# 43199-016-15

Storage

Store at 20°-25°C (68°-77°F) [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. 06/09

PRINCIPAL DISPLAY PANEL - 15 mL 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.)

PRINCIPAL DISPLAY PANEL - 15 mL Carton

ANTIPYRINE AND BENZOCAINE 
antipyrine and benzocaine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43199-016
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Antipyrine (Antipyrine) Antipyrine 54 mg  in 1 mL
Benzocaine (Benzocaine) Benzocaine 14 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Oxyquinoline  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43199-016-15 15 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/25/2009

Labeler - County line Pharmaceuticals, LLC (015585278)

Revised: 12/2009 County line Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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