MyOxin

chloroxylenol, benzocaine, and hydrocortisone acetate

Dosage Form: otic suspension
MyOxin™

otic suspension

Chloroxylenol 1 mg

Benzocaine 15 mg

Hydrocortisone Acetate 10 mg

Rx Only

MyOxin 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

MyOxin is effective both as an antibacterial and antifungal agent. The unique 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. MyOxin 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.

Indications and Usage for MyOxin

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.

MyOxin 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 MyOxin Supplied

MyOxin Otic Suspension is supplied in 15mL amber glass bottles with dosage dropper and package insert NDC 58809-333-15

Rx Only

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

Storage Conditions

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

Manufactured for

GMPharmaceuticals, Inc.

Arlington, TX 76012

Rev. 6/2011

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC 58809-333-15

MyOxin™

otic suspension

Chloroxylenol 1 mg

Benzocaine 15 mg

Hydrocortisone Acetate 10 mg

SHAKE WELL BEFORE USING

Rx Only

GMPharmaceuticals, Inc.

15 mL bottle

MyOxin  chloroxylenol, benzocaine, and hydrocortisone acetate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58809-333 Route of Administration TOPICAL 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 Acetate 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Water   PEG-12 Glyceryl Dimyristate   Polyoxyl 40 Castor Oil   Sodium Hydroxide   CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)   Isopropyl Alcohol   Xanthan Gum   Potassium Sorbate

Product Characteristics Color WHITE (milky) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58809-333-15 1 BOTTLE In 1 BOX contains a BOTTLE, GLASS 1 15 mL In 1 BOTTLE, GLASS This package is contained within the BOX (58809-333-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		08/01/2011

Labeler - GM Pharamceuticals, Inc (793000860)

Registrant - Sonar Products, Inc (104283945)

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

Revised: 07/2011GM Pharamceuticals, Inc

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