FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
FOR USE IN EARS ONLY- NOT FOR USE IN EYES
Discontinue promptly if sensitization or irritation occurs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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:
C11H12N2O
Mol. Wt. 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:
C9H11NO2
Mol. Wt. 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 (5.4%), Benzocaine 14 mg (1.4%); INACTIVES: Glycerin, Oxyquinoline Sulfate.
Sources
Painkoolers Pain Relief Patch Manufacturers
-
Pure Source
Painkoolers Pain Relief Patch | Bausch & Lomb Incorporated
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.
Use of Dropper:
Remove cap from bottle and discard. Remove dropper from package. Place dropper in bottle and use as directed. After use, do not rinse dropper and place dropper in bottle and close tightly.
NOTE: Do not use if solution is brown or contains a precipitate.
DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.
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