FDA records indicate that there are no current recalls for this drug.
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Aurax Otic Recall
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: FOR USE IN EARS ONLY, NOT FOR USE IN EYES. KEEP OUT OF REACH OF CHILDREN
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
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.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: Each mL contains:
Antipyrine.............................................................55.0 mg (5.5%)
Benzocaine.............................................................14.0 mg (1.4%)
(also contains glycerin and oxyquinoline sulfate)
Aurax 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. 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 ingredients are represented by the following structural formulas:
Sources
Aurax Otic Manufacturers
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Acella Pharmaceuticals, Llc
Aurax Otic | Acella Pharmaceuticals, Llc
DOSAGE AND ADMINISTRATION: ACUTE OTITIS MEDIA: Instill Aurax Otic Solution 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 Aurax Otic Solution and insert into the meatus. Repeat every one to two hours until pain and congestion are relieved.
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