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KANKA

Blistex Inc.

Blistex KANKA SoftBrush Tooth & Gum Pain Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

KANKA 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

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 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 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 2 years of age: consult a dentist or doctor
  • children under 12 years of age should be supervised in the use of this product

KANKA Other information

  • do not purchase if package has been opened
  • store at 20-25°C (68-77°F)
  • 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 Package

NDC 10157-9493-1

Blistex ®

PROFESSIONAL STRENGTH

KANKA ®

SoftBrush ®

Tooth & Gum Pain Gel

ORAL ANESTHETIC / ORAL 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

KANKA

Benzocaine and Zinc Chloride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10157-9493
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 20 mL
ZINC CHLORIDE 0.1 g

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
ETHYLPARABEN
GLYCERIN
METHYLPARABEN
polyethylene glycol 400
POLYETHYLENE GLYCOL 3350
PROPYLPARABEN
SILICON DIOXIDE
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 APPLICATOR
2 NDC:10157-9493-1 1 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2009-05-01


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