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Oticin Ear Drops

Generic Name: chloroxylenol and pramoxine hydrochloride
Dosage Form: ear drops

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Oticin Ear Drops

Oticin Ear Drops Description

Each 10 mL for otic administration contains:

Parachlorometaxylenol …..….. 0.010 gm

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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.

INACTIVE INGREDIENT

Oticin Ear Drops also contains propylene glycol USP as an inactive ingredient.

Oticin Ear Drops - Clinical Pharmacology

Parachlorometaxylenol in low concentrations is a germicide that may be used to treat bacterial and fungal infections. It is a halogenated phenol, non-toxic, non-corrosive, non-staining with a high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood.

Proxazocain HCl is a topical anesthetic which is chemically unrelated to procaine and the other "caines". It provides temporary relief from itching and pain by stabilizing the neuronal membranes of nerve endings with which it comes into contact.

Indications and Usage for Oticin Ear Drops

For the treatment of superficial infections of the external ear caused by microbes and to control the accompanying itching.

Contraindications

This medication is contraindicated in patients sensitive to any of the components of this preparation. This medication should not be applied in the external auditory canal where there is a perforated eardrum or when this medication can reach the middle ear.

Warnings

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.

Precautions

General

Treatment should not be continued for longer than ten days and the source of infection and/or inflammation or sensitization evaluated to determine whether therapy should be changed.

Information for Patients: Patients using this medication should be advised of the following:

• This medication is to be used as directed by a physician.

• Do not use this medication for any disorder other than for which it was prescribed. Check with your physician before using this medication for future ear problems.

• Report any signs of local adverse reactions to your physician.

• Keep this and all medications out of the reach of children. In case of accidental overdose or ingestion, seek professional assistance or contact a poison control center immediately.

• Store at controlled room temperature between 15(- 30(C (59(- 86(F).

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been performed to evaluate the carcinogenic or mutagenic potential of this product.

Pregnancy

Pregnancy category C: There are no adequate and well-controlled studies in pregnant women. Oticin Ear Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Oticin Ear Drops Dosage and Administration

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.

How is Oticin Ear Drops Supplied

Oticin Ear Drops are supplied as a clear liquid in plastic dropper vials of 10 mL, NDC 68436-115-10.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Storage: Store at 15(- 30(C (59(- 86(F).

Pharmacist: Protect from light. Dispense in this container.

Rx Only

Manufactured for:

Teral, Inc.

Ponce, P.R. 00716

500388    Iss. 05/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: Oticin Container Label

OTICIN 
chloroxylenol / pramoxine hcl solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68436-115
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.010 g  in 10 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 0.1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
Packaging
# Item Code Package Description
1 NDC:68436-115-10 1 BOTTLE, DROPPER (BOTTLE) in 1 PACKAGE
1 10 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/12/2009
Labeler - Teral, Inc. (186958810)
Registrant - Teral, Inc. (186958810)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE
Revised: 11/2009
 
Teral, Inc.



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