{"active_ingredient":["Active ingredients Benzocaine 200 mg (in each g)"],"do_not_use":["Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age"],"dosage_and_administration":["Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use"],"effective_time":"20250117","id":"faddc3dc-e19a-41aa-a279-5c00670ba73a","inactive_ingredient":["Inactive ingredients flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive."],"indications_and_usage":["Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M022"],"brand_name":["BENZOCAINE Raspberry","BENZOCAINE Bubble Gum","BENZOCAINE Cherry","BENZOCAINE Mint","BENZOCAINE Pina Colada","BENZOCAINE Strawberry"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Darby Dental Supply, LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["66467-4002-2","66467-4003-2","66467-4001-2","66467-4006-2","66467-4000-2","66467-4004-2"],"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":["66467-4000","66467-4002","66467-4003","66467-4001","66467-4006","66467-4004"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["238910"],"spl_id":["faddc3dc-e19a-41aa-a279-5c00670ba73a"],"spl_set_id":["dd805400-26c5-4c18-ade2-821298233f9b"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry","PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint","PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum","PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry","PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry","PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a physician before use."],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? 800-645-2310 or darby.com"],"set_id":"dd805400-26c5-4c18-ade2-821298233f9b","spl_product_data_elements":["BENZOCAINE Cherry Benzocaine WATER FD&C BLUE NO. 1 D&C GREEN NO. 5 FD&C RED NO. 3 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE BENZOCAINE Mint Benzocaine WATER FD&C BLUE NO. 1 D&C GREEN NO. 5 FD&C RED NO. 3 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE BENZOCAINE Bubble Gum Benzocaine WATER FD&C BLUE NO. 1 D&C GREEN NO. 5 FD&C RED NO. 3 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE BENZOCAINE Strawberry Benzocaine WATER FD&C BLUE NO. 1 D&C GREEN NO. 5 FD&C RED NO. 3 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE BENZOCAINE Raspberry Benzocaine WATER FD&C BLUE NO. 1 D&C GREEN NO. 5 FD&C RED NO. 3 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE BENZOCAINE Pina Colada Benzocaine WATER FD&C BLUE NO. 1 D&C GREEN NO. 5 FD&C RED NO. 3 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE DYE FREE Pina Colada"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information Store at 59° - 86°F (15 - 30°C). Protect from freezing."],"version":"7","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 the 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics. Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask a physician before use. Keep out of reach of children."],"when_using":["When using this product Avoid contact with eyes. If contact occurs, flush with water."]}