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Name:Antipyrine And Benzocaine
Manufacturer:Physicians Total Care, Inc.
Category:Prescription Marketed Drugs


ANTIPYRINE AND BENZOCAINE  - antipyrine and benzocaine solution 
Physicians Total Care, Inc.

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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DESCRIPTION

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.

image of antipyrine structure

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.
image of benzocaine structure

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.

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 bottle with a dropper tip under cap
NDC 54868-2034-0
15 mL plastic bottle with a dropper tip under cap
NDC 54868-2034-1

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


Relabeling of "Additional barcode" label by:
Physicians Total Care, Inc.
Tulsa, OK       74146


PRINCIPAL DISPLAY PANEL

Antipyrine and Benzocaine Otic Solution

10 mL

NDC 54868-2034-0

image of 10 mL package label


ANTIPYRINE AND BENZOCAINE 
antipyrine and benzocaine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2034(NDC:42192-708)
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
OXYQUINOLINE SULFATE  
GLYCERIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2034-0 10 mL in 1 BOTTLE, DROPPER None
2 NDC:54868-2034-1 15 mL in 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/24/1995

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 03/2011 Physicians Total Care, Inc.



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


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