KANK-A MOUTH PAIN- benzocaine liquid

Kank-A by

Drug Labeling and Warnings

Kank-A 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

Benzocaine 20.0% (w/w)

Purpose

Oral anesthetic/analgesic

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

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. 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 doctor or dentist 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:
  • 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

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, PEG-6, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38B (29.6% v/v), sodium saccharin, sucralose, tannic acid

PRINCIPAL DISPLAY PANEL - 9.75 mL Bottle Package

MAXIMUM
STRENGTH

Blistex®

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)

INGREDIENTS AND APPEARANCE

KANK-A   MOUTH PAIN
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9477
Route of Administration	BUCCAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASTOR OIL (UNII: D5340Y2I9G)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TANNIC ACID (UNII: 28F9E0DJY6)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9477-1	9.75 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/01/2011

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9477)