{"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals or humans have been conducted."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Combines the analgesic action of antipyrine and benzocaine with the skin protectant zinc acetate to relieve pressure, reduce inflammation and congestion, protect the skin, and alleviate pain and discomfort in acute otitis media."],"contraindications":["CONTRAINDICATIONS This 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 Each 1 mL for otic administration contains: Antipyrine 54 mg Benzocaine 10 mg Zinc Acetate Dihydrate 10 mg Also contains acetic acid, propylene glycol, glycerin, purified water, and vitamin E polyethylene glycol 1000 succinate. Antipyrine is an antipyretic and analgesic. Antipyrine occurs as a colorless, almost odorless, crystalline powder or tabular crystals having a slightly bitter taste. It is very soluble in water and freely soluble in alcohol. Chemically its structure is C 11 H 12 N 2 0. Benzocaine is a short-acting local anesthetic. Benzocaine occurs as a white, crystalline powder. Chemically its structure is C 9 H 11 NO 2 . Zinc acetate in the dihydrate form is a salt of zinc and a topical skin protectant generally recognized as safe and effective. Zinc acetate dihydrate occurs as white crystals or granules, is freely soluble in water and in boiling alcohol and is slightly soluble in alcohol. Chemically its structural formula is C 4 H 6 O 4 Zn•2H 2 O. TOPICAL DECONGESTANT, ANALGESIC, & SKIN PROTECTANT An otic solution containing antipyrine, benzocaine and zinc acetate dihydrate."],"description_table":["
Antipyrine 54 mg
Benzocaine 10 mg
Zinc Acetate Dihydrate 10 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Acute otitis media Warm to body temperature. Using a single bottle dropper, 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. 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."],"effective_time":"20160104","how_supplied":["HOW SUPPLIED OTOZIN is supplied as a clear liquid delivered in 2 white dropper bottles containing 10 mL each as a single prescription package (NDC 28595-420-20). Store at controlled room temperature 68°-77°F (20°-25°C). Protect from light."],"id":"0adb5445-6014-4cd4-9d4c-08b5e26eb1b4","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."],"mechanism_of_action":["Combines the analgesic action of antipyrine and benzocaine with the skin protectant zinc acetate to relieve pressure, reduce inflammation and congestion, protect the skin, and alleviate pain and discomfort in acute otitis media."],"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 - Two 10 mL Bottle Carton NDC: 28595-420-20 Rx ONLY otozin ™ Antipyrine 5.4% Benzocaine 1.0% Zinc Acetate Dihydrate 1.0% ALLEGIS PHARMACEUTICALS Canton, MS 39046 Two 10 mL Bottles PRINCIPAL DISPLAY PANEL - Two 10 mL Bottle Carton"],"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 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. 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."],"pregnancy":["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":"cd77f88e-8714-45ca-a385-1ca75b8c94bb","spl_product_data_elements":["Otozin Antipyrine, Benzocaine, and Zinc Acetate Antipyrine Antipyrine Benzocaine Benzocaine Zinc Acetate Zinc Cation Water Propylene Glycol Glycerin Acetic Acid"],"spl_unclassified_section":["Rx ONLY","Rx only KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. U.S. Patent # 6,093,417 Manufactured for: Allegis Pharmaceuticals Canton, MS 39046 Rev. 4/2011 T3.0"],"storage_and_handling":["Store at controlled room temperature 68°-77°F (20°-25°C). Protect from light."],"version":"2"}