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ANTIPYRINE AND BENZOCAINE solution
[SDA Laboratories]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

EAR SOLUTION

Topical Decongestant and Analgesic

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:

Chemical Structure
C11H12N2O        MW=188.22

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 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 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. 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 & Benzocaine Otic Solution is supplied in plastic bottles containing 15 mL (NDC# 66424-520-35).

A tamper evident seal is on the bottle cap. Do not dispense if the seal is broken.

Storage

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing.

Manufactured for:
SDA Laboratories
Greenwich, CT 06830
Ph: 800-687-0176

Iss. 06/10

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

SDA
LABORATORIES

NDC 66424-520-35

Antipyrine &
Benzocaine
Otic Solution, USP

EACH mL CONTAINS

Actives:

Antipyrine USP     54 mg
Benzocaine USP   14 mg

Inactive ingredients: Glycerine
(anhydrous), Oxyquinoline Sulfate.

FOR USE IN THE EARS ONLY

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

Rx only

15 mL (1/2 fl. oz.)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
ANTIPYRINE AND BENZOCAINE 
antipyrine and benzocaine solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:66424-520
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Antipyrine (Antipyrine) Antipyrine54 mg  in 1 mL
Benzocaine (Benzocaine) Benzocaine14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Oxyquinoline Sulfate 
Product Characteristics
ColorYELLOW (Slightly) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66424-520-3515 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/2000
Labeler - SDA Laboratories (948067889)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products Inc104283945MANUFACTURE(66424-520)

Revised: 11/2013
 
SDA Laboratories

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