Kank-A® with Blistex® Medicated Lip Ointment

Drug Labeling and Warnings

Drug Details [pdf]

KANK-A WITH BLISTEX MEDICATED LIP- benzocaine, dimethicone, camphor (synthetic), menthol, unspecified form, and phenol 
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® with Blistex® Medicated Lip Ointment

KANK-A®

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 rare but 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

For oral use only

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.

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

  • 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: consult a dentist or doctor

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

Blistex® MEDICATED LIP OINTMENT

Drug Facts Lip Ointment

Active ingredientsPurpose
Camphor 0.5% (w/w)External analgesic
Dimethicone 1.1% (w/w)Lip protectant
Menthol 0.625% (w/w)External analgesic
Phenol 0.5% (w/w)External analgesic

Uses

  • for the temporary relief of pain and itching associated with minor lip irritation or cold sores
  • temporarily protects and helps relieve chapped or cracked lips

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not get into eyes
  • do not apply over large areas of the body or bandage

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: Consult a doctor

Inactive ingredients

allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

PRINCIPAL DISPLAY PANEL - Blister Pack Kit

MAXIMUM
STRENGTH

Blistex®

KANKA®

MOUTH PAIN LIQUID

ORAL ANESTHETIC/ANALGESIC

BONUS
with this
purchase
see inside
back panel for
Lip Ointment
Drug Facts

Maximum
Pain Relief

Forms
Protective Coating

For Sores Inside
the Mouth

Canker Sores
Denture Abrasions
Brace Irritation

ADA
Accepted
American
Dental
Association
®

Net 0.33 fl. oz.
(9.75 mL)

PRINCIPAL DISPLAY PANEL - Blister Pack Kit
KANK-A WITH BLISTEX MEDICATED LIP 
benzocaine, dimethicone, camphor (synthetic), menthol, unspecified form, and phenol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10157-9893
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10157-9893-11 in 1 BLISTER PACK11/19/201808/08/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, WITH APPLICATOR 9.75 mL
Part 21 TUBE 6 g
Part 1 of 2
KANK-A 
benzocaine liquid
Product Information
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19.75 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/19/201808/08/2019
Part 2 of 2
BLISTEX MEDICATED LIP 
dimethicone, camphor (synthetic), menthol, unspecified form, and phenol ointment
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.625 g  in 100 g
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
LAURIC ACID (UNII: 1160N9NU9U)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
OLEIC ACID (UNII: 2UMI9U37CP)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/19/201808/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/19/201808/08/2019
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9893)

Revised: 8/2019
 
Blistex Inc.