Label: DENTEK CANKER COVER- menthol patch, extended release

  • 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 December 4, 2015

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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 not finalpart35612/01/2015
    Labeler - Bershtel Enterprises (066659129)
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