{"active_ingredient":["ACTIVE INGREDIENTS Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%"],"do_not_use":["DO NOT USE • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age"],"dosage_and_administration":["DIRECTIONS adults and children 2 years of age and older apply to the affected area up to 4 times daily or as directed by a dentist or doctor children between 2 and 12 years of age ask a doctor before use. Should be supervised in the use of this product. children under 2 years of age do not use"],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td>adults and children 2 years of age and older</td><td>apply to the affected area up to 4 times daily or as directed by a dentist or doctor</td></tr><tr><td>children between 2 and 12 years of age</td><td>ask a doctor before use. Should be supervised in the use of this product.</td></tr><tr><td>children under 2 years of age</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20250601","id":"38d791e8-33d3-22e4-e063-6394a90aff90","inactive_ingredient":["INACTIVE INGREDIENTS ammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water"],"indications_and_usage":["USES • for the temporary relief of • pain due to minor irritation or injury of the mouth and gums • occasional sore mouth and sore throat"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Orajel Rescue Relief Pen"],"generic_name":["ORAL PAIN RELIEVER"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-731-07","10237-731-27"],"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":["10237-731"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2362013"],"spl_id":["38d791e8-33d3-22e4-e063-6394a90aff90"],"spl_set_id":["2d68eec5-ae8a-9cdf-e063-6294a90a9799"],"substance_name":["ZINC CHLORIDE","MENTHOL","BENZOCAINE"],"unii":["86Q357L16B","L7T10EIP3A","U3RSY48JW5"]},"other_safety_information":["OTHER INFORMATION • do not use if package has been opened"],"package_label_principal_display_panel":["#1 ORAL PAIN RELIEF BRAND FOR ADULTS Orajel™ TOOTHACHE & GUM IMMEDIATE RELIEF OF: ORAL PAIN BRACE/DENTURE IRRITATION GUM DISCOMFORT CANKER SORES RESCUE RELIEF PEN GENTLE. TARGETED. TOUCH-FREE. PLUS COOLING RELIEF 50+ USES ORAL PAIN RELIEVER / ASTRINGENT NET WT 0.07 OZ (2.0 g) Orajel Pen"],"purpose":["PURPOSE Oral Pain Reliever / Oral Astringent"],"questions":["QUESTIONS OR COMMENTS? Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com"],"set_id":"2d68eec5-ae8a-9cdf-e063-6294a90a9799","spl_product_data_elements":["Orajel Rescue Relief Pen Oral Pain Reliever ZINC CHLORIDE ZINC CATION MENTHOL MENTHOL AMMONIUM GLYCYRRHIZATE WATER BENZOCAINE BENZOCAINE SORBIC ACID POLYETHYLENE GLYCOL 400 PEG-75 SODIUM SACCHARIN Pale yellow to tan"],"stop_use":["STOP USE AND ASK A DENTIST OR DOCTOR IF • sore throat is severe, persists for more than 2 days • sore mouth symptoms do not improve in 7 days • headache, nausea, vomiting, swelling, rash or fever develops • irritation, pain or redness persists or worsens"],"version":"2","warnings":["WARNINGS 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 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 DO NOT USE • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age STOP USE AND ASK A DENTIST OR DOCTOR IF • sore throat is severe, persists for more than 2 days • sore mouth symptoms do not improve in 7 days • headache, nausea, vomiting, swelling, rash or fever develops • irritation, pain or redness persists or worsens KEEP OUT OF REACH OF CHILDREN In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away."]}