FDA records indicate that there are no current recalls for this drug.
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12 Hour Nasal Decongestant Recall
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Questions & Answers
Side Effects & Adverse Reactions
This product is not intended for ophthalmic or oral use. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.
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
For the treatment of superficial infections of the external ear caused by microbes and to control the accompanying itching.
History
There is currently no drug history available for this drug.
Other Information
Each 10 mL for otic administration contains:
Parachlorometaxylenol …..….. 0.010 gm
Proxazocain HCl …………..…. 0.100 gm
Parachlorometaxylenol (4-chloro-3,5-xylenol) is a wide spectrum antimicrobial agent.
Proxazocain (p-butoxyphenyl γ-morpholinopropyl ether), used as the hydrochloride salt, is a topical anesthetic.
Sources
12 Hour Nasal Decongestant Manufacturers
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Cvs Pharmacy
12 Hour Nasal Decongestant | Teral, Inc.
The external ear that is the auricle and the auditory canal should be thoroughly cleansed and dried. Four (4) to five (5) drops of Oticin Ear Drops should be instilled into the affected ear 3 to 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for at least 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary for the opposite affected ear. If preferred, a gauze ear plug or wick may be inserted into the ear canal prior to applying Oticin Ear Drops. When using a wick, a few drops of sterile water should be applied directly to the wick following insertion to facilitate hydration. It should then be saturated with Oticin Ear Drops. The patient should be instructed to add a few drops of Oticin Ear Drops to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of Oticin Ear Drops should continue to be instilled 3 or 4 times daily thereafter. When using a gauze earplug, the external ear canal is first treated with drops of Oticin Ear Drops. Next, the gauze is inserted into the ear canal to contain medication. The gauze ear plug or the expanded wick are easily removed by fingers, forceps, or tweezers. This product may continue to be used in the unaffected ear 3 times daily as a preventative.
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