{"clinical_pharmacology":["CLINICAL PHARMACOLOGY Combines the properties of acetic acid, insect derived polycosanol 410 (with major component containing molecular weight of 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."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to any of the components or substances related to them. In the presence of spontaneous perforation or discharge."],"description":["DESCRIPTION Each mL contains: Acetic Acid………………………………………….…..0.01% Antipyrine………………………………………….….....5.4% Benzocaine………………………………………….........1.4% Polycosanol 410 (composesd of the following aliphatic alcohols: Octocosanol >70%, Hexacosanol 1.0 - 4.0%, Heptacosanol 0.0 - 3.0%, Nonacosanol 0.0 - 4.0%, Traicontanol 8.0 - 11.0%).................................0.01% Inactive Ingredient Glycerin (also contains Aluminum Acetate) TOPICAL ANESTHETIC, ANALGESIC AND ANTIBACTERIAL An otic solution containing acetic acid, antipyrine, benzocaine, polycosanol 410 and aluminum acetate. The solution congeals at 0°C (32°F) but returns to normal consistency, unchanged at room temperature. The structures of the components are: structure CLINICAL PHARMACOLOGY Combines the properties of acetic acid, insect derived polycosanol 410 (with major component containing molecular weight of 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."],"dosage_and_administration":["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 the dropper. Then moisten a cotton pledget with the product and insert into the 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. Important: Using the dropper applicator: Squeeze rubber bulb and insert the dropper into the bottle. Slowly release the bulb to allow the dropper to fill. DO NOT ALLOW MEDICINE TO GO INTO BULB."],"effective_time":"20180516","how_supplied":["HOW SUPPLIED AABP Otic Solution is supplied in a white 15 mL plastic bottle with a separate dropper-screw cap attachment and package insert (NDC 42192-701-15). Store at 20° - 25°C (68° - 77°F), excursions permitted at 15°- 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from freezing. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, incipients, inactive ingredients and chemical formulation information provided herein. QUESTIONS OR COMMENTS? 1-800-541-4802 MANUFACTURED FOR: Brookstone Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Rev. 8/2009v13"],"id":"672f0dd7-144e-4b2e-8316-1f43c06b7bdd","inactive_ingredient":["Inactive Ingredient Glycerin (also contains Aluminum Acetate) TOPICAL ANESTHETIC, ANALGESIC AND ANTIBACTERIAL An otic solution containing acetic acid, antipyrine, benzocaine, polycosanol 410 and aluminum acetate. The solution congeals at 0°C (32°F) but returns to normal consistency, unchanged at room temperature. The structures of the components are: structure"],"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."],"nursing_mothers":["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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 42192-701-15 AABP Otic Solution Rx Only 14 mL BROOKSTONE PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL"],"precautions":["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 clearly needed."],"set_id":"7945f753-9fb6-4cd4-ac9d-26c33efdeaf4","spl_product_data_elements":["AABP Otic Solution ACETIC ACID, ANTIPYRINE, BENZOCAINE ACETIC ACID ACETIC ACID ANTIPYRINE ANTIPYRINE BENZOCAINE BENZOCAINE GLYCERIN ALUMINUM ACETATE"],"spl_unclassified_section":["Rx Only","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE."],"version":"1"}