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ANTIPYRINE AND BENZOCAINE
benzocaine solution/ drops
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----------ANTIPYRINE AND BENZOCAINE
OTIC SOLUTION USP
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:
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.
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
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.
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.
FOR USE IN EARS ONLY-NOT FOR USE IN EYES
Information for Patients
Avoid contaminating the dropper with material from the ear, fingers or other source.
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.
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
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.
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
PRINCIPAL DISPLAY PANEL - 15 mL Carton
Each mL Contains the Active Ingredients:
county line pharmaceuticals, llc
15 mL (1/2 fl. oz.)
Revised: 12/2009 County line Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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