Oticin HC Ear Drops

Name: Oticin HC Ear Drops

Oticin HC Ear Drops Overview

Oticin HC Ear Drops is a brand name medication included in the following groups of medications: Phenol and derivatives, Anesthetics for topical use, Local anesthetics, Corticosteroids acting locally, Corticosteroids for local oral treatment, Antiinflammatory Corticosteroids, Corticosteroids, weak group I, Corticosteroids, weak, other combinations, Corticosteroids/antiinfectives/mydriatics in combination, Glucocorticoids. For more information about Oticin HC Ear Drops see its generics Chloroxylenol, Hydrocortisone, Pramocaine

Oticin HC Ear Drops - Clinical Pharmacology

Hydrocortisone is a corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory action of topical corticosteroids is unclear. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically-administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

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 HC Ear Drops

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

Oticin HC 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 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.

Package label.principal display panel

Figure 1

Figure 2: Oticin HC Container Label

OTICIN HC   EAR DROPS
pramoxine hcl / hydrocortisone / chloroxylenol solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68436-110
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.1 g  in 10 mL
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.01 g  in 10 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 0.01 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
POLOXAMER 188  
PROPYLENE GLYCOL  
PROPYLENE GLYCOL DIACETATE  
PROPYL GALLATE  
WATER  
Packaging
# Item Code Package Description
1 NDC:68436-110-10 1 BOTTLE, DROPPER 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 09/28/2015
Labeler - Teral, Inc. (186958810)
Registrant - Teral, Inc. (186958810)
Revised: 07/2015   Teral, Inc.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad ear irritation.
  • Burning.
  • Very bad itching.
(web3)