Kanka®

Kanka®
SPL v1
SPL
SPL Set ID 078fcdab-38a1-4a9a-bdd3-e17446591ea8
Route
ORAL
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Menthol, Unspecified Form (2 g)
Inactive Ingredients
Polyethylene Glycol, Unspecified Polyethylene Glycol 3350 Sucralose Phenoxyethanol Ascorbyl Palmitate Thymol Cetylpyridinium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 55105-1
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)
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
Do Not Use
  • for teething
  • in children under 2 years of age
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.

Other Information
  • www.kank-a.com
Inactive Ingredients

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

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.
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
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)


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 55105-1 (55105-1)
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)
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
Do Not Use (Do not use)
  • for teething
  • in children under 2 years of age
Allergy Alert (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.

Other Information (Other information)
  • www.kank-a.com
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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.
Methemoglobinemia Warning (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
Principal Display Panel 11.9 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

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