FDA.reportPublic FDA data

KANKA

Manufacturer
Blistex Inc
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:41

Label at a glance#

ProductKANKA SoftBrush
Active ingredientBENZOCAINE, ZINC CHLORIDE
Label structure8 sections

Indications and 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

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Benzocaine 20.0% (w/w)Oral anesthetic/analgesic
Zinc Chloride 0.1% (w/w)Oral astringent

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

METHEMOGLOBINEMIA WARNING

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • 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 ingredients

INACTIVE INGREDIENT SECTION

flavors, glycerin, PEG-8, PEG-75, phenoxyethanol, silica, sucralose

PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249105benzocaine 20 % / zinc chloride 0.1 % Oral GelPSN2
1249105benzocaine 0.2 MG/MG / zinc chloride 0.001 MG/MG Oral GelSCD2
1249105benzocaine 20 % / zinc chloride 0.1 % Oral GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-2106-1KANKA SoftBrush2 g in 1 APPLICATORGEL22
10157-2106-1KANKA SoftBrush1 in 1 BLISTER PACKGEL12
10157-2106-2KANKA SoftBrush2 g in 1 APPLICATORGEL22
10157-2106-2KANKA SoftBrush2 in 1 BLISTER PACKGEL22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-2106KANKA SOFTBRUSH (BENZOCAINE AND ZINC CHLORIDE) GEL [BLISTEX INC]2Current NDC, Legacy NDC, 4 package rows20241215_093f3545-1d8e-48a3-a533-e9c3ae6d740b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-210610157-2106-1, 10157-2106-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
ZINC CHLORIDE86Q357L16BACTIM
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KANKA SoftBrushBENZOCAINE AND ZINC CHLORIDEBlistex Inc093f3545-1d8e-48a3-a533-e9c3ae6d740b2024-12-12WarningsExact identifier
ndc (package): 10157-2106-2
ndc (package): 10157-2106-1
ndc (product): 10157-2106
ndc11 (package): 10157210601
ndc11 (package): 10157210602
spl id: bbba35d9-5dd7-4471-ad62-63061a9128a1
spl set id: 093f3545-1d8e-48a3-a533-e9c3ae6d740b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.