Oticin Hc Ear Drops label

Oticin Hc Ear Drops

Oticin Hc Ear Drops Recall

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Side Effects & Adverse Reactions

This product should be used with care in cases of long-standing otitis media because of the possible perforation of the eardrum concomitant with the external ear use of this product. This preparation is not intended for opthalmic or oral use. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

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 inflammation and itching.

History

There is currently no drug history available for this drug.

Other Information

Oticin HC Ear Drops is an anti-inflammatory, antimicrobial and local anesthetic solution for use in the external ear only.

Each 10 mL for otic administration contains:

Hydrocortisone ……………….. 0.100 gm

Parachlorometaxylenol …..….. 0.010 gm

Proxazocain HCl …………..…. 0.100 gm

Hydrocortisone (11β, 17, 21-trihydroxy pregn-4-ene-3, 20-dione) is an anti-inflammatory and antipruritic agent.

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.

Oticin Hc Ear Drops Manufacturers

  • Teral, Inc.
    Oticin Hc Ear Drops | Teral, Inc.
    No Recall

    Oticin Hc Ear Drops | Teral, Inc.

    Oticin Hc Ear Drops | Teral, Inc.

    The external ear, that is the auricle and the auditory canal should be thoroughly cleansed and dried. Four (4) to 5 drops of Oticin HC Ear Drops should be instilled into the affected ear 3 or 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 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 a wick may be inserted into the ear canal prior to applying Oticin HC 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 HC Ear Drops. The patient should be instructed to add a few drops of Oticin HC Ear Drops to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of Oticin HC Ear Drops should be instilled 3 or 4 times daily thereafter. When using a gauze ear plug, the external ear canal is first treated with drops of Oticin HC Ear Drops. Next, the gauze is inserted into the ear canal to contain the medication. The gauze ear plug or the expanded wick are easily removed using fingers, forceps, or tweezers.

    This product may be used in the unaffected ear 3 times daily as a preventative.