MyOxin

Each 1 mL for otic administration contains:

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.

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.

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.

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

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

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