KANKA TRIPLE ACTION- benzocaine and menthol, unspecified form gel

Kanka Triple Action by

Drug Labeling and Warnings

Kanka Triple Action by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Benzocaine 20.0% (w/w)	Oral anesthetic/analgesic; (oral pain reliever)
Menthol 2.0% (w/w)	Oral anesthetic/analgesic; (oral pain reliever)

Uses

• for the temporary relief of pain associated with canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums.

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.

Directions

• Adults and children 2 years of age and older: Apply to affected area up to 4 times daily or as directed by a dentist or doctor
• Children between 2 and 12 years of age: Ask a doctor before use. Should be supervised in the use of this product
• Children under 2 years of age: Do not use

Other information

• www.kank-a.com

Inactive ingredients

ascorbyl palmitate, cetylpyridinium chloride, PEG-75, phenoxyethanol, polyethylene glycol, sucralose, thymol

PRINCIPAL DISPLAY PANEL - 11.9 g Tube Carton

MAXIMUM STRENGTH

KANKA®

TRIPLE ACTION GEL
ORAL PAIN RELIEVER

Mouth Pain Relief for Canker Sores

Net Wt. 0.42 oz. (11.9 g)

INGREDIENTS AND APPEARANCE

KANKA TRIPLE ACTION 
benzocaine and menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2127
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
THYMOL (UNII: 3J50XA376E)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2127-1	1 in 1 CARTON	01/06/2025
1		11.9 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	01/06/2025

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-2127)