{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-01",
"results": {
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{
"spl_product_data_elements": [
"KANKA SoftBrush Benzocaine and ZINC CHLORIDE BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 GLYCERIN SUCRALOSE PHENOXYETHANOL SILICON DIOXIDE"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients Purpose Benzocaine 20.0% (w/w) Oral anesthetic/analgesic Zinc Chloride 0.1% (w/w) Oral astringent"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses for the temporary relief of pain due to toothaches, canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums"
],
"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 for teething in children under 2 years of age When using this product do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. do not exceed recommended dosage. Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."
],
"do_not_use": [
"Do not use for teething in children under 2 years of age"
],
"when_using": [
"When using this product do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. do not exceed recommended dosage."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."
],
"dosage_and_administration": [
"Directions adults and children 2 years of age and older: twist base clockwise to dispense. It may take up to 10 full turns to dispense the initial dose, but subsequent uses should require less than 1 turn. to clean brush tip, rinse with cold water dry affected area and apply medication by gently brushing the affected area. use up to 4 times daily, or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: do not use"
],
"storage_and_handling": [
"Other information do not purchase if package has been opened replace cap after use to prevent drying avoid contact with the eyes this is a personal care item, and should be used by one individual only with zinc chloride, some color may be evident; this is normal"
],
"inactive_ingredient": [
"Inactive ingredients flavors, glycerin, PEG-8, PEG-75, phenoxyethanol, silica, sucralose"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack Blistex ® MAXIMUM STRENGTH KANKA ® Soft Brush ® Tooth & Gum Pain Gel ORAL ANESTHETIC/ASTRINGENT Maximum Pain Relief Dual Medications Gentle Application Easy Reach Design Ultra Soft Tip 50+ Uses Toothaches Brace/Denture Irritation Gum Discomfort Canker Sores Net Wt. 0.07 oz. (2.0 g) PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack"
],
"set_id": "093f3545-1d8e-48a3-a533-e9c3ae6d740b",
"id": "bbba35d9-5dd7-4471-ad62-63061a9128a1",
"effective_time": "20241212",
"version": "2",
"openfda": {
"application_number": [
"M022"
],
"brand_name": [
"KANKA SoftBrush"
],
"generic_name": [
"BENZOCAINE AND ZINC CHLORIDE"
],
"manufacturer_name": [
"Blistex Inc"
],
"product_ndc": [
"10157-2106"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"BENZOCAINE",
"ZINC CHLORIDE"
],
"rxcui": [
"1249105"
],
"spl_id": [
"bbba35d9-5dd7-4471-ad62-63061a9128a1"
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"spl_set_id": [
"093f3545-1d8e-48a3-a533-e9c3ae6d740b"
],
"package_ndc": [
"10157-2106-1",
"10157-2106-2"
],
"is_original_packager": [
true
],
"upc": [
"0041388203928"
],
"nui": [
"N0000185508",
"N0000175629",
"N0000184306",
"M0000728"
],
"pharm_class_epc": [
"Standardized Chemical Allergen [EPC]"
],
"pharm_class_pe": [
"Increased Histamine Release [PE]",
"Cell-mediated Immunity [PE]"
],
"pharm_class_cs": [
"Allergens [CS]"
],
"unii": [
"U3RSY48JW5",
"86Q357L16B"
]
}
}
]
}