Blistex® KANKA® SoftBrush® Tooth & Gum Pain Gel

Drug Labeling and Warnings

Drug Details [pdf]

KANKA  SOFTBRUSH- benzocaine and zinc chloride gel 
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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Blistex® KANKA® SoftBrush®
Tooth & Gum Pain Gel

Drug Facts

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 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

• 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
• adults and children 2 years of age and older: 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: consult a dentist or doctor

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

butylparaben, ethylparaben, flavors, glycerin, methylparaben, PEG-8, PEG-75, propylparaben, silica, sucralose

PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack

Blistex®

MAXIMUM STRENGTH

KANKA®

SoftBrush®

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)

KANKA   SOFTBRUSH
benzocaine and zinc chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9493
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	20 g  in 100 g
Zinc Chloride (UNII: 86Q357L16B) (Zinc cation - UNII:13S1S8SF37)	Zinc cation	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
polyethylene glycol 400 (UNII: B697894SGQ)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
propylparaben (UNII: Z8IX2SC1OH)
silicon dioxide (UNII: ETJ7Z6XBU4)
sucralose (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9493-1	1 in 1 BLISTER PACK	05/01/2009	08/05/2019
1		2 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 10157-9493-2	2 in 1 BLISTER PACK	05/01/2009	08/05/2019
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	05/01/2009	08/05/2019

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9493)

Revised: 8/2019

Document Id: 906da0df-8dd9-4ba5-bcb6-7c0e84aa7290

34390-5

Set id: c246d8a9-ccf8-431e-8026-5fdfaf789760

Version: 4

Effective Time: 20190806

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