{"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["CARCONOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: No long-term studies in animals or humans have been conducted."],"clinical_pharmacology":["Aurodex TM Antipyrine and Benzocaine Otic Solution comibine 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":["Contraindications: Aurodex TM Antipyrine and Benzocaine Otic Solution is contraindicated in any person with hypersensitivity to any of the components or substances related tot hem. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge."],"description":["DESCRIPTION: Each mL contains: Antipyrine..........54 mg (5.4%) Benzocaine..........14.0 mg (1.4%) (also contains glycerin and oxyquinoline sulfate) Aurodex TM Antipyrine and Benzocaine Otic Solution is an otic solution containing antipyrine, benzocaine, oxyquinoline sulfate and anhydrous glycerin for use in the ear. The solution congeals at 0 o C (32 o F) but returns to normal consistency, unchanged at room temperature. Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phyl-3-pyrazolin-5-one. Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol. Benzocaine is a local anesthetic. it is chemically ethyl-p-aminobenzoate or Benzoic Acid, 4-amino, ethyl ester. The active ingredients are represented by the following structural formula antipyrine benzocaine"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: ACUTE OTITIS MEDIA: Instill Aurodex TM Antipyrine and Benzocaine Otic Soution 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 Aurodex TM Antipyrine Benzocaine Otic Solution and insert into the meatus. Repeat every one to two hours until pain an congestion are relieved. REMOVAL OF CERUMEN: Before: Instill Aurodex TM Antipyrine and Benzocaine Otic Solution three times daily for 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 or relieving discomfort. Before and after removal of cerumen, a cotten pledget moistened with Aurodex TM 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 6 MONTHS AFTER OPENING."],"effective_time":"20171113","how_supplied":["How Supplied: Aurodex TM Antipyrine and Benzocaine Otic Solution is supplied in a 10 mL plastic botle with a dropper tip under cap (NDC 0904-6317-10). Store at 20 o -25 o C (68 o -77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) see USP Controlled Room Temperature). Protect from light and heat. Manufactured by: Sonar Products, Inc Carlstadt, NJ 07072 Usual Dosage: See package insert for complete information. Storage: Store at 20o-25oC (68o-77oF); excursions permitted to 15o-30oC (59o-86oF) see USP Controlled Room Temperature). Protect from light and heat. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured by: Sonar Products, Inc Carlstadt, NJ 07072 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA"],"id":"4e20e06b-18d1-4d85-bb8a-e61195a22e75","indications_and_usage":["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, epecially 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":["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 exercised when Aurodex TM Antipyrine and Benzocaine Otic Solution is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["Auroded TM Antipyrine and Benzocaine Otic Solution USP Rx only 10mL FOR USE IN THE EARS ONLY. NOT FOR USE IN THE EYES Active Ingredients Each mL contains: Antipyrine...54.0 mg (5.4%) Benzocaine....14mg (1.4%) Also contains: Glycerin and Oxyquinoline Sulfate Aurodex Otic Solution"],"precautions":["Precautions: Information for Patients: Avoid contaminating the dropper tip with material from the ear fingers or other source."],"pregnancy":["PREGNANCY CATEGORY C: Animal reproduction 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 fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aurodex TM Antipyrine and Benzocaine Otic Solution should be given to a pregnant woman only if clearly needed."],"set_id":"fa67ddca-a12e-4798-b170-843cd8e7afeb","spl_product_data_elements":["Aurodex ANTIPYRINE, BENZOCAINE OTIC ANTIPYRINE ANTIPYRINE BENZOCAINE BENZOCAINE OXYQUINOLINE SULFATE GLYCERIN"],"version":"5","warnings":["Warnings: FOR USE IN EARS ONLY NOT FOR USE IN EYES KEEP OUT OF REACH OF CHILDREN Discontinue promptly if sensitization or irritation occurs."]}