Kank-a®

Kank-a®
SPL v5
SPL
SPL Set ID eebc03ba-f849-4e70-a653-834f383b6aa4
Route
BUCCAL
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Benzyl Alcohol Cetylpyridinium Chloride Compound Benzoin Tincture Dimethyl Isosorbide Ethylcellulose, Unspecified Acrylate/butylaminoethyl Methacrylate/methyl Acrylate/methyl Methacrylate/octylacrylamide Copolymer (40000 Wamw) Oleth-10 Polyethylene Glycol, Unspecified Polyethylene Glycol 300 Propylene Glycol Castor Oil Alcohol Saccharin Sodium Sucralose Tannic Acid

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-12-01

Description

Drug Facts

Purpose

Oral anesthetic/analgesic


Medication Information

Purpose

Oral anesthetic/analgesic

Description

Drug Facts

Uses
  • for the temporary relief of pain due to 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.

Directions
  • adults and children 2 years of age and older:
    • to assure formation of a long-lasting film coating, dry affected area and apply medication undiluted with applicator
    • allow a few seconds for coating to form
    • 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
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.

Active Ingredient

Benzocaine 20.0% (w/w)

Other Information
  • do not purchase if package has been opened
  • cap tightly after use to avoid evaporation
  • avoid contact with the eyes
  • avoid contact with clothing and household/furniture surfaces to prevent possible staining
  • this is a personal care item, and should be used by one individual only
Inactive Ingredients

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38-B (29.6% v/v), sodium saccharin, sucralose, tannic acid

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 9.75 Ml Bottle Package

MAXIMUM STRENGTH

KANK-A®

MOUTH PAIN LIQUID

ORAL ANESTHETIC

Maximum Pain Relief

Forms Protective Coating

For Sores Inside the Mouth

Canker Sores

Denture Abrasions

Brace Irritation

ADA

Accepted

American

Dental

Association ®

CONVENIENT

CONTROL-TIP

APPLICATOR

Net 0.33 fl. oz. (9.75 mL)


Structured Label Content

Uses
  • for the temporary relief of pain due to 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.

Purpose

Oral anesthetic/analgesic

Directions
  • adults and children 2 years of age and older:
    • to assure formation of a long-lasting film coating, dry affected area and apply medication undiluted with applicator
    • allow a few seconds for coating to form
    • 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
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.

Active Ingredient (Active ingredient)

Benzocaine 20.0% (w/w)

Other Information (Other information)
  • do not purchase if package has been opened
  • cap tightly after use to avoid evaporation
  • avoid contact with the eyes
  • avoid contact with clothing and household/furniture surfaces to prevent possible staining
  • this is a personal care item, and should be used by one individual only
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38-B (29.6% v/v), sodium saccharin, sucralose, tannic acid

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 9.75 Ml Bottle Package (PRINCIPAL DISPLAY PANEL - 9.75 mL Bottle Package)

MAXIMUM STRENGTH

KANK-A®

MOUTH PAIN LIQUID

ORAL ANESTHETIC

Maximum Pain Relief

Forms Protective Coating

For Sores Inside the Mouth

Canker Sores

Denture Abrasions

Brace Irritation

ADA

Accepted

American

Dental

Association ®

CONVENIENT

CONTROL-TIP

APPLICATOR

Net 0.33 fl. oz. (9.75 mL)


Advanced Ingredient Data


Raw Label Data

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