Otozin

Dosage Form: topical solution
Otozin™

Antipyrine 5.4%

Bemzpcaome 1.0%

Zinc Acetate Dihydrate 1.0%

Rx ONLY

Otozin 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 C11H12N20.

Benzocaine is a short-acting local anesthetic. Benzocaine occurs as a white, crystalline powder. Chemically its structure is C9H11NO2.

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 C4H6O4Zn•2H2O.

TOPICAL DECONGESTANT, ANALGESIC, & SKIN PROTECTANT

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

Otozin - 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.

Indications and Usage for Otozin

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.

Otozin 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 is Otozin 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

Otozin  antipyrine, benzocaine, and zinc acetate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 28595-420-20 2 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: 05/2011Allegis Pharmaceuticals, LLC

More Otozin resources

• Otozin Side Effects (in more detail)
• Otozin Use in Pregnancy & Breastfeeding
• Otozin Support Group
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