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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KANKA®
SoftBrush

Drug Facts

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

Uses

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

Other information

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)

PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack
KANKA   SOFTBRUSH
benzocaine and zinc chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-2106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mg  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-2106-11 in 1 BLISTER PACK09/25/2019
12 g in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:10157-2106-22 in 1 BLISTER PACK09/25/2019
22 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/25/2019
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-2106)

Revised: 9/2019
Document Id: 63ce9e63-4c32-40c4-a18e-3daae1860150
Set id: 093f3545-1d8e-48a3-a533-e9c3ae6d740b
Version: 1
Effective Time: 20190927
 
Blistex Inc