{"active_ingredient":["Active Ingredient Benzocaine 20%"],"dosage_and_administration":["Directions Adults & children, 12 yrs of age & older ■ Apply to the affected area up to 4 times daily or as directed by a dentist or doctor. Children 2 yrs of age & older ■ As directed by a dentist or doctor. Children under 2 years of age ■ Do not use."],"effective_time":"20251010","id":"40d07e93-4ae8-9c91-e063-6394a90ac00a","inactive_ingredient":["Inactive Ingredients Clove Oil, Ethyl Alcohol, Glycerin, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Sodium Methylparaben."],"indications_and_usage":["Uses Uses ■ for the temporary relief of pain due to. ■ toothache ■ minor irritation or injury of the mouth & gums ■ irritation cause by dentures or orthodontic appliances ■ sore gums."],"keep_out_of_reach_of_children":["Warnings Warnings: Do not exceed recommended dosage Keep out of reach of children In case of overdose, get medical help immediately. Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: Pale, gray, or blue colored skin (cyanosis), Headache, Rapid heart rate, Shortness of breath, Dizziness or lightheadedness, Fatigue or lack of energy. Do not use: for more than 7 days unless directed by a dentist or doctor for teethings in children under 2 years of age. Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Stop use and ask a dentist or doctor if: sore mouth symptoms do not improve in 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops. These symptoms may be a sign of infection or a serious condition."],"openfda":{"application_number":["M022"],"brand_name":["Anesgerm LA MUELA Fast Pain Relief"],"generic_name":["BENZOCAINE 20%"],"is_original_packager":[true],"manufacturer_name":["Germa Products, LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["73635-7101-5"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["73635-7101"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["308657"],"spl_id":["40d07e93-4ae8-9c91-e063-6394a90ac00a"],"spl_set_id":["bf7842a2-9c0b-3fc3-e053-2995a90a36c1"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"],"upc":["0790933101935"]},"other_safety_information":["Other Information Store between 15º to 30ºC (59º to 86ºF)."],"package_label_principal_display_panel":["Anesgerm La Muela"],"purpose":["Purpose Pain Reliever"],"set_id":"bf7842a2-9c0b-3fc3-e053-2995a90a36c1","spl_product_data_elements":["Anesgerm LA MUELA Fast Pain Relief Benzocaine 20% PROPYLENE GLYCOL SACCHARIN SODIUM GLYCERIN CLOVE OIL POLYETHYLENE GLYCOL 100000 BENZOCAINE BENZOCAINE ALCOHOL METHYLPARABEN SODIUM"],"version":"6","warnings":["Warning Warnings: Do not exceed recommended dosage. Keep out of reach of children. In case of overdose, get medical help immediately. Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before."],"when_using":["Do Not Use if Do not use ■ for more than 7 days unless directed by a dentist or doctor ■ for teethings. ■ in children under 2 years of age. Allergy alert ■ do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Stop use and ask a dentist or doctor if ■ sore mouth symptoms do not improve in 7 days ■ irritation, pain or redness persists or worsens ■ swelling, rash or fever develops. ■ These symptoms may be a sign of infection or a serious condition."]}