Aurodex

AURODEX- antipyrine and benzocaine solution
Preferred Pharmaceuticals, Inc

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.

Each mL Contains

Antipyrine …………………………………………………..54.0mg (5.4%)

Benzocaine ………………………………………………….14.0mg (1.4%)

(also contains glycerine and oxyquinoline sulfate)

Aurodextm Antipyrine and Benzocaine Otic Solution combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and alleviate pain and discomfort in acute otitis media. Aurodextm Antipyrine and Benzocaine Otic Solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

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 rsolution of the infection.

Because the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequesnt 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

Aurodextm Antipyrine and Benzocaine Otic Solution is contraindicated in any person with hypersensitivty 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


FOR USE IN EARS ONLY, NOT FOR USE IN EYES. KEEP OUT OF REACH OF CHILDREN.

Discontinue prompptly if sensitization or irritation occurs.

INFORMATION FOR PATIENTS:

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

No long term studies in animals or humans have been conducted

CATEGORY C: Animal reproductive studies have not been conducted with Aurodextm Antipyrine and Benzocaine Otic Solution. It is also not known whether Aurodextm Antipyrine and Benzocaine Otic Solution can cause harm when adminstered to a pregnant woman, or can affect reproduction capacity. Aurodextm Antipyrine and Benzocaine Otic Solution should be given to a pregnant woman onli if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercized when Aurodextm Antipyrine and Benzocaine Otic Solution is administered to a nursing woman

Instill Aurodextm Antipyrine and Benzocaine Otic Solution 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 Antipyrine and Benzocaine Otic Solution and insert into the meatus. Repeat every one to two hours until pain and congestion are relieved.

REMOVAL OF CERUMEN: Before: instll Aurodextm Antipyrine and Benzocaine Otic Solution three time daily fro two to three days to help detach cerumen from wall of canal and facilitate removal.

After: Aurodextm Antipyrine and Benzocaine Otic Solution is useful for drying out the canal and reliving discomfort.

Before and after removal of cerumen, a cotton pldget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following installation.

Note: After use, do not rinse dropper tip. Replace cap and close tightly.

Protect solution from light and heat, and do not use if it is brown or contains a precipitate.

DISCARD THIS PRODUCT SIX MONTHS AFTER OPENING


Aurodextm Antipyrine and Benzocaine Otic Solution is supplied in a 15 mL plastic bottle with a dropper tip under cap and package insert attached

NDC (68788-0008-01)

Store at 20o — 25o C (68o -77o F). Excursions permitted to 15o — 30o C (59o -786o F).

Manufactured By:

Sonar Products

Carlstadt, NJ 07072

Distributed By:

Major Pharmaceuticals

Livonia, MI

Relabeled by:

Preferred Pharmaceuticals, Inc

Anaheim, CA 92807

Aurodex Antipyrine & Benzocaine Otic Solution, USP
(click image for full-size original)

AURODEX
a/b otic drops solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-0008(NDC:0904-6317)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIPYRINE (ANTIPYRINE) ANTIPYRINE 54 mg in 1 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
OXYQUINOLINE SULFATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-0008-1 15 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/18/2010
Labeler — Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc 791119022 REPACK (68788-0008)

Revised: 05/2013 Preferred Pharmaceuticals, Inc

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