{"active_ingredient":["Active ingredients Purpose Hydrogen peroxide 1.5% Oral debriding agent/Oral antiseptic Menthol 0.1% Oral pain reliever"],"active_ingredient_table":["<table width=\"60%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Hydrogen peroxide 1.5%</td><td>Oral debriding agent/Oral antiseptic</td></tr><tr><td>Menthol 0.1%</td><td>Oral pain reliever</td></tr></tbody></table>"],"do_not_use":["Do not use this product for more than 7 days unless directed by a dentist or healthcare provider"],"dosage_and_administration":["Directions remove imprinted safety seal from bottle cap to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age and older Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider Children under 12 years of age Should be supervised in the use of this product Children under 2 years of age Consult a dentist or healthcare provider"],"dosage_and_administration_table":["<table width=\"60%\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Adults and children 2 years of age and older</td><td>Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Children under 12 years of age</td><td>Should be supervised in the use of this product</td></tr><tr><td styleCode=\"Rrule\">Children under 2 years of age</td><td>Consult a dentist or healthcare provider</td></tr></tbody></table>"],"effective_time":"20241127","id":"27eb6e9e-5cd7-d08a-e063-6394a90ad5b6","inactive_ingredient":["Inactive ingredients disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water"],"indications_and_usage":["Uses first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures accidental injury orthodontic appliances canker sores dentures other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth"],"keep_out_of_reach_of_children":["Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M022"],"brand_name":["Orajel 2x Gum Pain Alcohol-Free"],"generic_name":["MENTHOL AND HYDROGEN PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"package_ndc":["10237-799-16"],"product_ndc":["10237-799"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2584344"],"spl_id":["27eb6e9e-5cd7-d08a-e063-6394a90ad5b6"],"spl_set_id":["adf37010-922c-4441-93d6-1e1a95025e90"],"substance_name":["MENTHOL, UNSPECIFIED FORM","HYDROGEN PEROXIDE"],"unii":["L7T10EIP3A","BBX060AN9V"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473.2 mL Bottle Label 1# ORAL PAIN RELIEF BRAND FOR ADULTS Orajel ™ 2X GUM PAIN RINSE MEDICATED ALCOHOL FREE EFFECTIVE ORAL PAIN RELIEF Soothes & Cools Gums Kills Harmful Bacteria Promotes Healing Relieves Gum Irritation Caused by Dentures or Braces ORAL DEBRIDING AGENT/ ANTISEPTIC RINSE/PAIN RELIEVER Soothing MINT 16 FL OZ (473.2 mL) OJLBF-01904-01 72025286 Principal Display Panel - 473.2 mL Bottle Label"],"purpose":["Active ingredients Purpose Hydrogen peroxide 1.5% Oral debriding agent/Oral antiseptic Menthol 0.1% Oral pain reliever"],"purpose_table":["<table width=\"60%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Hydrogen peroxide 1.5%</td><td>Oral debriding agent/Oral antiseptic</td></tr><tr><td>Menthol 0.1%</td><td>Oral pain reliever</td></tr></tbody></table>"],"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":"adf37010-922c-4441-93d6-1e1a95025e90","spl_product_data_elements":["Orajel 2x Gum Pain Alcohol-Free Menthol and Hydrogen Peroxide EDETATE DISODIUM ANHYDROUS FD&C BLUE NO. 1 METHYL SALICYLATE PHOSPHORIC ACID POLOXAMER 338 POLYSORBATE 20 PROPYLENE GLYCOL SACCHARIN SODIUM SORBITOL WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM HYDROGEN PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days"],"storage_and_handling":["Other information cap tightly keep away from heat or direct sunlight do not use if safety seal is broken or missing"],"version":"2","warnings":["Warnings Do not use this product for more than 7 days unless directed by a dentist or healthcare provider When using this product do not swallow do not exceed recommended dosage Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away"],"when_using":["When using this product do not swallow do not exceed recommended dosage"]}