MyOxin

MYOXIN- chloroxylenol, benzocaine and hydrocortisone acetate solution
GM Pharamceuticals, Inc

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.

Chloroxylenol 1 mg
Benzocaine 15 mg
Hydrocortisone Acetate 10 mg

Rx Only

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 PHARMACOLOGY 1

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.

MyOxin Indications and Usage

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 to MyOxin

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.

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 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

PRINCIPAL DISPLAY PANEL -- 15 mL Bottle Carton
(click image for full-size original)
MYOXIN
chloroxylenol, benzocaine, and hydrocortisone acetate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC:58809-333-15 1 BOTTLE, GLASS (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: 07/2011 GM Pharamceuticals, Inc

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