Label: DENTEK CANKER COVER- menthol patch, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active Ingredient

    menthol: 2.5 mg

  • Keep Out of Reach of Children Section

    Warning: Keep out of reach of children.

  • Purpose Section

    For Relief of pain associated with: canker sores & mouth sores.

  • Ask Doctor

    Consult your dentist or doctor before using.

  • Indications & Usage

    Adult and Children 5 year of age and older.

    The sore should be dry (pat with tissue) is possible. Place the Canker Cover Patch on a clean, dry finger with the white side up. Place the white side on the sore and hold in place for 20 seconds. Within 30 minutes the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before disolving. DO NOT REMOVE PATCH BEFORE IT DISSOLVES.

  • Dosage & Administration

    2.5 mg per patch

  • Questions section

    Call us 800-4Dentek (433-6835) M-F 8am - 5am EST or email us at Info@Dentek.com

  • Warning Section

    Keep out of reach of children. If irritation, pain, or redness worsens, if swelling, rash or fever develops, or if sore mouth systoms persists for 7 days, see your doctor or dentist.

  • Inactive Ingredients

    1. citrus medica fruit
    2. povidone
    3. colloidal silicon dioxide
    4. carbomer 934
    5. Xylitol
    6. Hydroxypropyl
    7. sea salt
    8. magnesium stearate
  • PRINCIPAL DISPLAY PANEL

    consumer box

  • INGREDIENTS AND APPEARANCE
    DENTEK CANKER COVER 
    menthol patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-0910
    Route of AdministrationTRANSMUCOSAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 194.85 
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POVIDONE (UNII: FZ989GH94E)  
    HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT)  
    SEA SALT (UNII: 87GE52P74G)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color    Score    
    ShapeROUNDSize9mm
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10564-0910-21 in 1 CARTON; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/01/2015
    Labeler - Bershtel Enterprises (066659129)
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