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 June 22, 2018

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  • SPL UNCLASSIFIED SECTION

  • Active ingredient (per each patch)

    Menthol 2.5 mg

  • Purpose

    Oral pain reliever

  • Uses

    for the temporary relief of pain associated with: 

    • canker sores
    • mouth sores
    • minor irritation of the mouth and gums.
  • Warnings

    Stop use and ask a dentist or doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness worsens
    • swelling, rash or fever develops

    If pregnant or breast-feeding or taking prescription drugs,

    ask a health care professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 5 years of age and older, apply up to 3 times a day, as needed
      The sore should be dry (pat with tissue) if possible. Place the 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. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the patch along the score and use half. Some discomfort may occur during the first few minutes, but will quickly subside, followed by hours of soothing relief. Within 30 minutes the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before dissolving. Do not remove the patch before it dissolves. In case of discomfort, the patch may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the patch. 
    • children under 5 years, ask a doctor
  • Other information

    store in a cool dry place.

  • Inactive ingredients

    annatto, carbomer homopolymer type a, flavor, hydroxypropyl cellulose, potassium magnesium chloride hydrate, povidone K30, povidone K90, silicon dioxide, xylitol

  • Questions

    800-4DENTEK (433-6835)

  • PRINCIPAL DISPLAY PANEL

    DenTek
    CANKER COVER
    CANKER SORE PATCH
    6 COUNT

    DenTek CANKER COVER CANKER SORE PATCH 6 COUNT

  • INGREDIENTS AND APPEARANCE
    DENTEK CANKER COVER 
    menthol patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-091
    Route of AdministrationTRANSMUCOSAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 194.85 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANNATTO (UNII: 6PQP1V1B6O)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-091-026 in 1 CARTON11/11/2015
    1NDC:60630-091-012.5 mg in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35611/11/2015
    Labeler - DenTek Oral Care, Inc. (153818646)
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