FDA.reportPublic FDA data

Anadent Kanka Gel

Manufacturer
BELMORA LLC
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:08

Label at a glance#

ProductAnadent Kanka Gel
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

For the temporary relief of pain due to toothache To help protect against infection of minor oral irritation.

Dosage and administration

Cut open tip of tube on score mark Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. 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

Do not use if tip is cut prior to opening This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted Do not use continuously This formula will stay in place for extended duration of relief Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

oral pain reliever

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain due to toothache
  • To help protect against infection of minor oral irritation.

Warnings

WARNINGS SECTION

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

  • more than directed   • for more than 7 days unless told to do so by a dentist or doctor
  • for teething    • in children under 2 years of age

Stop use and ask a dentist or doctor if 

  • swelling, rash or fever develops    • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days   • allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cut open tip of tube on score mark
  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. 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 use if tip is cut prior to opening
  • This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • Do not use continuously
  • This formula will stay in place for extended duration of relief
  • Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid

SPL UNCLASSIFIED SECTION

20% BENZOCAINE TO RELIEVE ORAL PAIN 

COOLS GUM & RELIEVES IRRITATION

For toothaches

Toothache and Gum pain Relief Gel

TAMPER-EVIDENT:

Do not use if tube is cut prior to use.
Retain carton for complete product information.

Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com
Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BELMORA-177BELMORA-177

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN2
238910benzocaine 0.2 MG/MG Oral GelSCD2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27854-177-01Anadent Kanka Gel1 in 1 CARTONGEL12
27854-177-01Anadent Kanka Gel7 g in 1 TUBEGEL72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-177ANADENT KANKA GEL (BENZOCAINE) GEL [BELMORA LLC]2Current NDC, Legacy NDC, 2 package rows20241009_e0f73d78-5db1-43b4-8f58-e5410ca4560f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-17727854-177-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBIC ACIDX045WJ989BIACT

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
Anadent Kanka GelBENZOCAINEBELMORA LLCe0f73d78-5db1-43b4-8f58-e5410ca4560f2024-10-04WarningsExact identifier
ndc (package): 27854-177-01
ndc (product): 27854-177
ndc11 (package): 27854017701
spl id: 36e537e0-993c-42d9-ac41-227cdcd5dfe3
spl set id: e0f73d78-5db1-43b4-8f58-e5410ca4560f

Reported adverse events (FAERS/openFDA)#

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