{"active_ingredient":["Active ingredients (in each gram) Benzocaine 200 mg"],"do_not_use":["Do not use for teething in children under 2 years of age"],"dosage_and_administration":["Directions adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain children under 2 years of age: do not use"],"effective_time":"20211001","id":"0cfa1933-ee1f-4b02-84e2-64c6e31fd29a","inactive_ingredient":["Inactive ingredients flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5, FD&C Blue #1 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. In case of overdose, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M022"],"brand_name":["KOLORZ TOPICAL ANESTHETIC TRIPLE MINT","KOLORZ TOPICAL ANESTHETIC CHERRY BURST","KOLORZ TOPICAL ANESTHETIC COTTON CANDY","KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY","KOLORZ TOPICAL ANESTHETIC PINA COLADA"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["DMG AMERICA, LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["25047-751-01","25047-752-01","25047-753-01","25047-754-01","25047-755-01"],"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":["25047-751","25047-752","25047-753","25047-754","25047-755"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["238910","856886"],"spl_id":["0cfa1933-ee1f-4b02-84e2-64c6e31fd29a"],"spl_set_id":["0f90b227-f938-4e1a-a79e-1967b1a0477e"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Triple Mint Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Triple Mint 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Triple Mint","PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cherry Burst Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Cherry Burst 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cherry Burst","PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cotton Candy Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Cotton Candy 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cotton Candy","PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Blue Raspberry Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Blue Raspberry 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Blue Raspberry","PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Piña Colada Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Piña Colada 1 FL OZ (29.6 grams) RINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Piña Colada"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, consult a doctor before use."],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? 800-6626383 • www.dmg-america.com"],"set_id":"0f90b227-f938-4e1a-a79e-1967b1a0477e","spl_product_data_elements":["KOLORZ TOPICAL ANESTHETIC TRIPLE MINT Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC CHERRY BURST BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC COTTON CANDY BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC PINA COLADA BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1"],"spl_unclassified_section":["Drug Facts","Distributed by DMG America LLC 242 South Dean St., Englewood, NJ 07631"],"storage_and_handling":["Other information Store at 59 - 86°F (15 - 30°C). Protect from freezing."],"version":"3","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 heartrate 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 benzocaine or other \"caine\" anesthetics. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsen, see your dentist or doctor promptly. Do not use for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. If pregnant or breast feeding, consult a doctor before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately."],"when_using":["When using this product Avoid contact with eyes. If contact occurs, flush with water."]}