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Antipyrine and Benzocaine Ear Drops

Dosage Form: otic solution

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.

ANTIPYRINE AND BENZOCAINE OTIC SOLUTION

Rx Only

DESCRIPTION:

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:

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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 55 mg (5.5%), Benzocaine 14 mg (1.4%); Inactives: Glycerin (anhydrous), Oxyquinoline Sulfate.

CLINICAL PHARMACOLOGY:

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:

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. 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 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:

Antipyrine and Benzocaine Otic Solution is supplied in a plastic light-resistant dropper-bottle with a screwtop cap containing 14 mL (NDC# 58657-480-14).

Tamper evident seal is on the bottle cap. Do not use if seal is broken or missing.

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. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at (877) 250-3427.

KEEP OUT OF REACH OF CHILDREN

Rx Only

Manufactured for:
Method Pharmaceuticals, LLC
Arlington, TX 76006               www.methodpharm.com

Rev. 10/14

PRINCIPAL DISPLAY PANEL

NDC 58657-480-14
ANTIPYRINE AND
BENZOCAINE
OTIC SOLUTION
Rx Only
      14 mL

ANTIPYRINE AND BENZOCAINE OTIC 
antipyrine and benzocaine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58657-480
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIPYRINE (ANTIPYRINE) ANTIPYRINE 55 mg  in 1 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE 14 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
OXYQUINOLINE SULFATE  
Packaging
# Item Code Package Description
1 NDC:58657-480-14 14 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/01/2014
Labeler - Method Pharmaceuticals, LLC (060216698)
Revised: 12/2014
 
Method Pharmaceuticals, LLC



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