FDA records indicate that there are no current recalls for this drug.
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Otic Care Antipyrine And Benzocaine Recall
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Questions & Answers
Side Effects & Adverse Reactions
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
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:
- Rapid pain relief and reduction of inflammation in the congestive and serous stages of otitis media.
- Adjuvant therapy during systemic antibiotic administration.
- Facilitates the removal of excessive or impacted earwax.
History
There is currently no drug history available for this drug.
Other Information
Each mL contains:
Antipyrine...........................................5.4%
Benzocaine........................................1.4%
TOPICAL ANESTHETIC AND ANALGESIC:
Otic Care Otic Solution contains antipyrine, benzocaine, acetic acid, aluminum acetate, aluminum oxide, glycerin and policosanol. The solution congeals at 0°C (32°F) but returns to normal consistency, unchanged at room temperature.
The structures of the components are:
Sources
Otic Care Antipyrine And Benzocaine Manufacturers
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Puretek Corporation
Otic Care Antipyrine And Benzocaine | Puretek Corporation
Warm to body temperature (37°C or 98°F) by holding the bottle in the hand for a few minutes. To apply eardrops, wash your hands first. To avoid contamination do not touch the dropper or let it touch your ear or any surface. Instill Otic Care Otic Solution by tilting the affected ear upward, holding the dropper directly over the ear, and placing the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted about two minutes. Moisten a cotton pledget with Otic Care Otic Solution and insert into the opening of the ear canal. Repeat every one to two hours until pain and congestion is relieved.
Instill Otic Care Otic Solution three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.
Otic Care Otic Solution is useful for drying out the canal or relieving discomfort.
Before and after removal of cerumen, insert a cotton pledget saturated with Otic Care Otic Solution into the meatus.If swallowed or overdose is suspected, contact your local Poison Control Center or emergency room immediately. You may call US National Poison Hotline at 1-800-222-1222.
Note: Do not rinse dropper after use.
Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly.
Protect the solution from light and heat, and do not use if it is brown or contains a precipitate.
DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.
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