ANADENT KANKA GEL- benzocaine gel

Anadent Kanka Gel by

Drug Labeling and Warnings

Anadent Kanka Gel by is a Otc medication manufactured, distributed, or labeled by BELMORA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

oral pain reliever

Uses

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

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

• 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

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

Directions

• 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

• 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:

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

INGREDIENTS AND APPEARANCE

ANADENT KANKA GEL 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-177
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-177-01	1 in 1 CARTON	04/15/2022
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	04/15/2022

Labeler - BELMORA LLC (112753244)