{"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["No long term studies in animals or humans have been conducted"],"clinical_pharmacology":["Aurodex tm 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. Aurodex tm Antipyrine and Benzocaine Otic Solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture."],"contraindications":["Aurodex tm 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"],"description":["Each mL Contains Antipyrine ...........................................................54.0mg (5.4%) Benzocaine ..........................................................14.0mg (1.4%) (also contains glycerine and oxyquinoline sulfate)"],"dosage_and_administration":["Instill Aurodex tm 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 Aurodex tm 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: Aurodex tm 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"],"effective_time":"20130730","how_supplied":["Aurodex tm 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 20 o - 25 o C (68 o -77 o F). Excursions permitted to 15 o - 30 o C (59 o -786 o F). Manufactured By: Sonar Products Carlstadt, NJ 07072 Distributed By: Major Pharmaceuticals Livonia, MI Relabeled by: Preferred Pharmaceuticals, Inc Anaheim, CA 92807"],"id":"1ab3c38a-dc03-47cf-b34b-19c81790507f","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 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"],"nursing_mothers":["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 Aurodex tm Antipyrine and Benzocaine Otic Solution is administered to a nursing woman"],"openfda":{},"package_label_principal_display_panel":["Aurodex Antipyrine & Benzocaine Otic Solution, USP"],"precautions":["INFORMATION FOR PATIENTS: Avoid contaminating the dropper tip with material from the ear, fingers or other source."],"pregnancy":["CATEGORY C: Animal reproductive studies have not been conducted with Aurodex tm Antipyrine and Benzocaine Otic Solution. It is also not known whether Aurodex tm Antipyrine and Benzocaine Otic Solution can cause harm when adminstered to a pregnant woman, or can affect reproduction capacity. Aurodex tm Antipyrine and Benzocaine Otic Solution should be given to a pregnant woman onli if clearly needed."],"set_id":"303fe47e-444e-4ecf-9346-622c4db8a311","spl_product_data_elements":["Aurodex A/B Otic Drops ANTIPYRINE ANTIPYRINE BENZOCAINE BENZOCAINE GLYCERIN OXYQUINOLINE SULFATE"],"version":"5","warnings":["FOR USE IN EARS ONLY, NOT FOR USE IN EYES. KEEP OUT OF REACH OF CHILDREN. Discontinue prompptly if sensitization or irritation occurs."]}