Treagan Otic Solution

Dosage Form: otic solution
Treagan Otic Solution

Description

Each ml contains:

acetlc acid...........................................................  0.01%

antipyrine ..............................................................5.4%

benzocaine .......................................................... 1.4%

polycosanol 410 (synthetic mixture).......................  0.01%

Also contains aluminum acetate.

Inactive Ingredient: Glycerin.

TOPICAL ANESTHETIC, ANALGESIC AND ANTIBACTERIAL: An otic solution

containing acetic acid, antipyrine, benzocaine, polycosanol410 and aluminum

acetate. The solution congeals at 0oC (32oF) but returns to normal consistency,

unchanged at room temperature. The structures of the components are:

Clinical Pharmacology

Combines the property of acetic acid, polycosanol 410 and aluminum acetate with the analgesic action of antipyrine and the local anesthetic action of benzocaine to relieve pressure, reduce inflammation and

congestion, and alleviate pain and discomfort in acute otitis media. Does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

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

Hypersensitivity to any of the components or substances related to them. In the presence of spontaneous perforation or discharge.

Precautions

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 dearly 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. Instill the product permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with the product and insert into meatus, 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

Treagan Otic Solution is supplied in a 15 ml plastic bottle with dropper and package insert. (NDC 13811-512-15).

Store at 20-·250C (68--770F). See USP Controlled RoomTemperature. Protect from freezing.

Bottle label

Example of bottle label

TREAGAN OTIC  antipyrine benzocaine otic  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-512 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 14 mg  in 1 mL Antipyrine (Antipyrine) Antipyrine 54 mg  in 1 mL Acetic Acid (Acetic Acid) Acetic Acid 0.1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-512-15 14 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2009

Labeler - Trigen Laboratories, Inc. (830479668)

Revised: 04/2010Trigen Laboratories, Inc.

More Treagan Otic Solution resources

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