{"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies have been conducted."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Antipyrine and Benzocaine Otic Solution, USP combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and to alleviate pain and discomfort in acute otitis media. Antipyrine and Benzocaine Otic Solution, USP does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture."],"contraindications":["CONTRAINDICATIONS: The product is contraindicated in any person with hypersensitivity 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":["DESCRIPTION: Antipyrine and Benzocaine Otic Solution, USP is an otic solution containing Antipyrine, Benzocaine, 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-phenyl-3-pyrazolin-5-one. The active ingredient is represented by the structural formula: C 11 H 12 N 2 O MW=188.23 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 ingredient is represented by the structural formula: C 9 H 11 NO 2 MW=165.19 It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents. County Line Pharmaceuticals Antipyrine Structural Formula County Line Pharmaceuticals Benzocaine Structural Formula"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Acute otitis media: Instill Antipyrine and Benzocaine Otic Solution, USP, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution, USP and insert into meatus. Repeat every one to two hours until pain and congestion are relieved. Removal of Cerumen: Before: Instill Antipyrine and Benzocaine Otic Solution, USP three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal. After: Antipyrine and Benzocaine Otic Solution, USP is useful for drying out the ear canal or relieving discomfort. Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution, USP should be inserted into the meatus following instillation."],"effective_time":"20150720","how_supplied":["HOW SUPPLIED: Antipyrine and Benzocaine Otic Solution, USP is supplied in a 15 mL tight light-resistant bottle. Tamper evident seal on bottle cap. Do not use if seal is torn, broken or missing. 15 mL bottle NDC# 43199-016-15 Storage: Store at 20 o -25 o C (68 o -77 o F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing. Keep tightly closed. Manufactured for: County Line Pharmaceuticals, LLC Brookfield, WI 53005 1-866-207-5636 Rev. 10/11"],"id":"3e7b6fa6-c788-48c1-a772-97257b445bee","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, 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."],"information_for_patients":["Information for Patients: Avoid contaminating the dropper with material from the ear, fingers or other source."],"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 Antipyrine and Benzocaine Otic Solution, USP is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - CARTON NDC# 43199-016-15 Antipyrine and Benzocaine Otic Solution USP Each mL Contains the Active Ingredients: Antipyrine USP 54 mg Benzocaine USP 14 mg Rx Only county line pharmaceuticals, llc 15 mL (1/2 fl. oz.) County Line Pharmaceuticals Antipyrine and Benzocaine Otic Solution Carton Label"],"precautions":["PRECAUTIONS: Information for Patients: Avoid contaminating the dropper with material from the ear, fingers or other source. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies have been conducted. Pregnancy: Category C. Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution, USP. It is also not known whether Antipyrine and Benzocaine Otic Solution, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution, USP should be given to a pregnant woman only if clearly needed. 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 Antipyrine and Benzocaine Otic Solution, USP is administered to a nursing woman."],"pregnancy":["Pregnancy: Category C. Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution, USP. It is also not known whether Antipyrine and Benzocaine Otic Solution, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution, USP should be given to a pregnant woman only if clearly needed."],"set_id":"800fdd10-693b-406b-a2fe-35da0df29298","spl_product_data_elements":["Antipyrine and Benzocaine Antipyrine and Benzocaine ANTIPYRINE ANTIPYRINE BENZOCAINE BENZOCAINE GLYCERIN"],"spl_unclassified_section":["FOR USE IN THE EARS ONLY Topical Decongestant and Analgesic Rx Only","EACH mL CONTAINS: Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerin (anhydrous)"],"storage_and_handling":["Storage: Store at 20 o -25 o C (68 o -77 o F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing. Keep tightly closed."],"version":"3","warnings":["WARNINGS: FOR USE IN EARS ONLY - NOT FOR USE IN EYES Discontinue promptly if sensitization or irritation occurs."]}