KANK-A  MOUTH PAIN- benzocaine liquid 
Blistex Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kank-A®
Mouth Pain Liquid

Drug Facts

Active ingredient

Benzocaine 20.0% (w/w)

Purpose

Oral anesthetic/analgesic

Uses

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

Other information

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)

Principal Display Panel - 9.75 mL Bottle Package
KANK-A   MOUTH PAIN
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9477
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9477-19.75 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/01/2011
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9477)

Revised: 9/2019
Document Id: 25efaeae-7405-47f6-9db1-9f15106ced37
Set id: eebc03ba-f849-4e70-a653-834f383b6aa4
Version: 3
Effective Time: 20190926
 
Blistex Inc.