Label: KANKA SOFTBRUSH- benzocaine and zinc chloride gel

  • NDC Code(s): 10157-2106-1, 10157-2106-2
  • Packager: Blistex Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 27, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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)

    PRINCIPAL DISPLAY PANEL - 2.0 g Applicator Blister Pack
  • INGREDIENTS AND APPEARANCE
    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)
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