TriOxin Ear Drops

chloroxylenol, benzocaine and hydrocortisone acetate

Dosage Form: otic suspension
TriOxin OTIC SUSPENSION

Rx Only

TriOxin Ear Drops Description

Each 1 mL for otic administration contains:

Chloroxylenol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Benzocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 mg

Hydrocortisone Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . 10 mg

INACTIVE INGREDIENTS: PEG-12 Glyceryl Dimyristate, Sodium Hydroxide, PEG-40 HCO, Purified Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Potassium Sorbate, Isopropyl Alcohol.

CLINICAL PHARMACOLOGY1

TriOxin is effective both as an antibacterial and antifungal agent. The unique Hydrophilic Lipid based delivery system provides a suspension having an acid pH and a low surface tension, exerting a drying effect and allowing the medication to spread quickly to all contiguous surfaces, softening and reducing accumulated cerumen. Chloroxylenol is a halogenated phenol; non-toxic, non-corrosive, non-staining with high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood. TriOxin which contains hydrocortisone acetate is indicated when otitis is complicated by inflammation or to control itching. Benzocaine is a topical anesthetic with a low index of sensitization and toxicity.

1

van Asperen IA, de Rover CM, Schijven JF, et al. Risk of otitis externa after swimming in recreational fresh water lakes containing Pseudomonas aeruginosa. BMJ.1995;311:1407-1410.

Sander R. Otitis Externa: A Practical Guide to Treatment and Prevention. Available at http://www.aafp.org/afp/20010301/927.html. Accessed 4/9/09.

BioZone Laboratories, Inc. Qusomes™. Available at: http://www.biozonelabs.com/html/qusomes/qusomes.htm. Accessed 4/15/09.

Indications and Usage for TriOxin Ear Drops

For the treatment of superficial infections of the external auditory canal complicated by inflammation caused by organisms susceptible to the action of the antimicrobial. May also be used to control itching in the auditory canal.

Contraindications

Topical steroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the components of this preparation. The preparation is not to be used for ophthalmic use and should not be applied in the external auditory canal of patients with perforated eardrums.

Warnings

This preparation is not intended for ophthalmic or oral use. If accidental ingestion occurs, seek professional help. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

Precautions

General

If a favorable response does not occur promptly, discontinue the use of this preparation until the infection is controlled by other appropriate measures. Although systemic side effects are not common with topical corticosteroids, the possibility of occurrence must be kept in mind, particularly when used for an extended period of time.

USAGE IN PREGNANCY

The safety of topical steroid preparations during pregnancy has not been established. Therefore, they should not be used on pregnant patients.

Adverse Reactions

The following adverse reactions with topical corticosteroids have been observed: itching, burning, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentations, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

OVERDOSE

Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects.

TriOxin Ear Drops Dosage and Administration

SHAKE WELL BEFORE USING. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 to 5 drops of the suspension 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 ear.

How is TriOxin Ear Drops Supplied

TriOxin Otic Suspension is supplied in 15mL amber glass bottles with dosage dropper and package insert. NDC 68025-041-15

Rx Only

Storage Conditions

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

05/09

Manufactured for

VERTICAL PHARMACEUTICALS, INC.

Sayreville, NJ 08872

Lipid Base Delivery System

QuSomes™

US Patent No. 6,610,322

US Patent No. 6,958,160

US Patent No. 7,150,883

Other patents may apply

PRINCIPAL DISPLAY PANEL-Sample Label

NDC 68025-041-02

TriOxin

Rx Only

Otic Suspension

(Chloroxylenol 1 mg, Benzocaine 15 mg,

Hydrocortisone Acetate10 mg)

2 mL

PRINCIPAL DISPLAY PANEL-Sample Carton

Physician Samples - not for resale

TriOxin

Rx Only

Otic Suspension

Each 1 mL for otic administration contains:

Chloroxylenol . . . . . . . . . . . . . . . 1 mg

Benzocaine . . . . . . . . . . . . . . . 15 mg

Hydrocortisone Acetate . . . . . 10 mg

Manufactured for:

VERTICAL

PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL-15 mL Carton

NDC 68025-041-15

15 mL bottle

TriOxin

Rx Only

Otic Suspension

Each 1 mL for otic administration contains:

Chloroxylenol . . . . . . . . . . . . . . . 1 mg

Benzocaine . . . . . . . . . . . . . . . 15 mg

Hydrocortisone Acetate . . . . . 10 mg

• Antibacterial and antifungal penetration

   using the QuSomes™ delivery system*

• Local anesthetic agent for pain relief*

• Local anti-inflammatory agent to

   reduce ear canal swelling*

*Please see Package insert

SHAKE WELL BEFORE USING

Manufactured for:

VERTICAL

PHARMACEUTICALS, INC.

Lipid Base Delivery System

QuSomes™

US Patent No. 6,610,322

US Patent No. 6,958,160

US Patent No. 7,150,883

Other patents may apply

TRIOXIN  chloroxylenol, benzocaine and hydrocortisone acetate  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68025-041 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chloroxylenol (Chloroxylenol) Chloroxylenol 1 mg  in 1 mL BENZOCAINE (BENZOCAINE) BENZOCAINE 15 mg  in 1 mL Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68025-041-02 12 BOTTLE In 1 BOX contains a BOTTLE 1 2 mL In 1 BOTTLE This package is contained within the BOX (68025-041-02) 2 68025-041-15 1 BOTTLE In 1 BOX contains a BOTTLE 2 15 mL In 1 BOTTLE This package is contained within the BOX (68025-041-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved other		07/02/2009

Labeler - Vertical Pharmaceuticals, Inc (173169017)

Establishment
Name	Address	ID/FEI	Operations
Sonar Products, Inc.		104283945	MANUFACTURE

Revised: 06/2009Vertical Pharmaceuticals, Inc

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