Kanka®

Kanka®
SPL v2
SPL
SPL Set ID 093f3545-1d8e-48a3-a533-e9c3ae6d740b
Route
ORAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 mg) Zinc Cation (0.1 g)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Glycerin Sucralose Phenoxyethanol Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-25

Description

Drug Facts


Medication Information

Description

Drug Facts

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
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
Zinc Chloride 0.1% (w/w) Oral astringent
Directions
  • 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
Do Not Use
  • for teething
  • in children under 2 years of age
Other Information
  • 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

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

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 2.0 G Applicator Blister Pack

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)


Structured Label Content

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
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
Zinc Chloride 0.1% (w/w) Oral astringent
Directions
  • 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
Do Not Use (Do not use)
  • for teething
  • in children under 2 years of age
Other Information (Other information)
  • 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 ingredients)

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

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 2.0 G Applicator Blister Pack (PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)