{"adverse_reactions":["ADVERSE REACTIONS Benzocaine can cause a hypersensitivity reaction consisting of rash, urticaria and edema. Individuals frequently exposed to ester-type local anesthetics can develop contact dermatitis characterized by erythema and pruritus. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis which can be treated by intravenous methylene blue. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Benzocaine acts by blocking conduction in nerve fibers as a result of decreased nerve cell membrane permeability to sodium ions or competition with calcium ions for membrane binding sites."],"contraindications":["CONTRAINDICATIONS Pinnacaine Otic Drops is contraindicated in patients sensitive to benzocaine. This medication should not be applied in the external auditory canal if there is a perforated eardrum or ear discharge."],"description":["DESCRIPTION ACTIVE INGREDIENT: Benzocaine.....................20% in an aqueous base. Benzocaine, a local anesthetic, is chemically, ethyl p-aminobenzoate, C 9 H 11 NO 2 , with a molecular weight of 165.19."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Administer 4-5 drops of Pinnacaine Otic Drops in the external ear canal and then insert a cotton pledget into the meatus. Can be repeated every 1 to 2 hours, if necessary."],"effective_time":"20151110","general_precautions":["General Medication should be discontinued if sensitivity or irritation occurs."],"how_supplied":["HOW SUPPLIED Pinnacaine Otic Drops, NDC# 68047-057-15, is supplied in a 15 mL amber glass bottle with dropper and package insert. Storage and Handling Store at 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Store in a tight, light-resistant Container. [See USP.} Keep bottle tightly closed. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Iss. 07/11"],"id":"24374b99-d342-454b-e054-00144ff8d46c","inactive_ingredient":["INACTIVE INGREDIENTS Glycerin, Polyethylene Glycol, Benzethonium Chloride, Purified Water."],"indications_and_usage":["INDICATIONS AND USAGE Pinnacaine Otic Drops may be used as a topical anesthetic in the external auditory canal to relieve ear pain. It may be used in the treatment of acute otitis media, acute swimmer’s ear and other forms of otitis externa."],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women."],"openfda":{},"overdosage":["OVERDOSAGE Effects of benzocaine overdosage may include yawning, restlessness, excitement, nausea and vomiting. Treatment is symptomatic. Please call your local Poison Control Center or your doctor if you suspect an overdosage of this product."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: 15 mL container label Figure 2: 15 mL carton b55e894b-figure-01 b55e894b-figure-02"],"pediatric_use":["Pediatric Use Do not use in infants under 1 year of age."],"precautions":["PRECAUTIONS General Medication should be discontinued if sensitivity or irritation occurs. Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted. Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women. Pediatric Use Do not use in infants under 1 year of age."],"pregnancy":["Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed."],"set_id":"e22a729e-ea74-407c-980d-0a1c15352419","spl_product_data_elements":["Pennacaine benzocaine BENZETHONIUM CHLORIDE GLYCERIN POLYETHYLENE GLYCOL 400 WATER BENZOCAINE BENZOCAINE"],"storage_and_handling":["Storage and Handling Store at 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Store in a tight, light-resistant Container. [See USP.} Keep bottle tightly closed. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Iss. 07/11"],"version":"3","warnings":["WARNINGS KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE. Use of anesthetic ear drops indiscriminately may mask symptoms of infection of the middle ear."]}