KANKA SOFTBRUSH- benzocaine and zinc chloride gel

KANKA by

Drug Labeling and Warnings

KANKA 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

Active ingredients	Purpose
Benzocaine 20.0% (w/w)	Oral anesthetic/analgesic
Zinc Chloride 0.1% (w/w)	Oral astringent

Uses

• for the temporary relief of pain due to toothaches, 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. 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

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 dentist or doctor 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:
  • twist base clockwise to dispense. It may take up to 10 full turns to dispense the initial dose, but subsequent uses should require less than 1 turn.
  • to clean brush tip, rinse with cold water
  • dry affected area and apply medication by gently brushing the affected area.
  • 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
• replace cap after use to prevent drying
• avoid contact with the eyes
• this is a personal care item, and should be used by one individual only
• with zinc chloride, some color may be evident; this is normal

Inactive ingredients

flavors, glycerin, PEG-8, PEG-75, phenoxyethanol, silica, sucralose

PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack

Blistex®

MAXIMUM STRENGTH
KANKA®

Soft Brush®
Tooth & Gum Pain Gel
ORAL ANESTHETIC/ASTRINGENT

Maximum Pain Relief

Dual Medications

Gentle Application

Easy Reach Design
Ultra Soft Tip
50+ Uses

Toothaches
Brace/Denture Irritation
Gum Discomfort
Canker Sores

Net Wt.
0.07 oz. (2.0 g)

INGREDIENTS AND APPEARANCE

KANKA   SOFTBRUSH
benzocaine and zinc chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mg  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2106-1	1 in 1 BLISTER PACK	09/25/2019
1		2 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 10157-2106-2	2 in 1 BLISTER PACK	09/25/2019
2		2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/25/2019

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-2106)