Otozin

OTOZIN- antipyrine, benzocaine and zinc acetate solution
Allegis Pharmaceuticals, LLC

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.

Rx ONLY

DESCRIPTION

Each 1 mL for otic administration contains:

Antipyrine 54 mg
Benzocaine 10 mg
Zinc Acetate Dihydrate 10 mg

Also contains acetic acid, propylene glycol, glycerin, purified water, and vitamin E polyethylene glycol 1000 succinate.

Antipyrine is an antipyretic and analgesic. Antipyrine occurs as a colorless, almost odorless, crystalline powder or tabular crystals having a slightly bitter taste. It is very soluble in water and freely soluble in alcohol. Chemically its structure is C11 H12 N2 0.

Benzocaine is a short-acting local anesthetic. Benzocaine occurs as a white, crystalline powder. Chemically its structure is C9 H11 NO2 .

Zinc acetate in the dihydrate form is a salt of zinc and a topical skin protectant generally recognized as safe and effective. Zinc acetate dihydrate occurs as white crystals or granules, is freely soluble in water and in boiling alcohol and is slightly soluble in alcohol. Chemically its structural formula is C4 H6 O4 Zn•2H2 O.

TOPICAL DECONGESTANT, ANALGESIC, & SKIN PROTECTANT

An otic solution containing antipyrine, benzocaine and zinc acetate dihydrate.

CLINICAL PHARMACOLOGY

Combines the analgesic action of antipyrine and benzocaine with the skin protectant zinc acetate to relieve pressure, reduce inflammation and congestion, protect the skin, and alleviate pain and discomfort in acute otitis media.

Otozin Indications and Usage

Acute otitis media of various etiologies

  • Prompt relief of pain and reduction of inflammation in the congestive and serous stages.
  • Adjuvant therapy during systemic antibiotic administration for resolution of the infection.

Because of the close anatomical relationship of the Eustachian tube to the nasal cavity, otitis media is a frequent problem especially in children in whom the tube is shorter, wider and more horizontal than in adults.

Removal of cerumen

  • Facilitates the removal of excessive or impacted cerumen.

CONTRAINDICATIONS

This product is contraindicated in any person with hypersensitivity to any of the components or substances related to them. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.

PRECAUTIONS

Information for Patients

Avoid contaminating the dropper with material from the ear, fingers or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals or humans have been conducted.

Pregnancy Category C

Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Caution should be exercised when this product is administered to a nursing woman.

DOSAGE AND ADMINISTRATION

Acute otitis media

Warm to body temperature. Using a single bottle dropper, instill the product permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with the dropper. Repeat every one to two hours until pain and congestion are relieved.

Removal of cerumen

Before

Instill three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.

After

This product is useful for drying out the canal or relieving discomfort. Before and after removal of cerumen a cotton pledget moistened with the product should be inserted into the meatus following instillation.

HOW SUPPLIED

OTOZIN is supplied as a clear liquid delivered in 2 white dropper bottles containing 10 mL each as a single prescription package (NDC 28595-420-20).

Store at controlled room temperature 68°-77°F (20°-25°C). Protect from light.

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.

U.S. Patent # 6,093,417

Manufactured for:
Allegis Pharmaceuticals
Canton, MS 39046

Rev. 4/2011

T3.0

PRINCIPAL DISPLAY PANEL — Two 10 mL Bottle Carton

NDC: 28595-420-20

Rx ONLY

otozin
Antipyrine 5.4%
Benzocaine 1.0%
Zinc Acetate Dihydrate 1.0%

ALLEGIS PHARMACEUTICALS
Canton, MS 39046

Two 10 mL Bottles

PRINCIPAL DISPLAY PANEL -- Two 10 mL Bottle Carton
(click image for full-size original)
OTOZIN
antipyrine, benzocaine, and zinc acetate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:28595-420
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Antipyrine (Antipyrine) Antipyrine 54 mg in 1 mL
Benzocaine (Benzocaine) Benzocaine 10 mg in 1 mL
Zinc Acetate (Zinc) Zinc Acetate 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
Propylene Glycol
Glycerin
Acetic Acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:28595-420-20 2 BOTTLE, DROPPER (BOTTLE) in 1 BOX contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (28595-420-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/06/2011
Labeler — Allegis Pharmaceuticals, LLC (792272861)

Revised: 05/2011 Allegis Pharmaceuticals, LLC

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