Search by Drug Name or NDC

NDC 10157-9477-01 Kank-A 200 mg/mL Details

Kank-A 200 mg/mL

Kank-A is a BUCCAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc.. The primary component is BENZOCAINE.

Product Information

NDC	10157-9477
Product ID	10157-9477_25efaeae-7405-47f6-9db1-9f15106ced37
Associated GPIs	88350010002030
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Kank-A
Proprietary Name Suffix	Mouth Pain
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	BUCCAL
Active Ingredient Strength	200
Active Ingredient Units	mg/mL
Substance Name	BENZOCAINE
Labeler Name	Blistex Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10157-9477-01 (10157947701)

Pricing Information	N/A
NDC Package Code	10157-9477-1
Billing NDC	10157947701
Package	9.75 mL in 1 BOTTLE, WITH APPLICATOR (10157-9477-1)
Marketing Start Date	2011-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eebc03ba-f849-4e70-a653-834f383b6aa4 Details

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)

Principal Display Panel - 9.75 mL Bottle Package

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Blistex Inc. (005126354)

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

Revised: 9/2019

Document Id: 25efaeae-7405-47f6-9db1-9f15106ced37

Set id: eebc03ba-f849-4e70-a653-834f383b6aa4

Version: 3

Effective Time: 20190926