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Treagan Otic Solution

Generic Name: antipyrine benzocaine
Dosage Form: otic solution

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.

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.

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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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:13811-512-15 14 mL in 1 BOTTLE, PLASTIC
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: 04/2010
 
Trigen Laboratories, Inc.



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