Label: DENTEMP CANKER COVER- canker cover tablet, extended release

  • NDC Code(s): 73653-212-01, 73653-212-04
  • Packager: DOC Brands
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient (per each tablet)

    Menthol 2.5 mg

  • Purpose

    Ora pain reliever

  • Indications

    for the temporary relief of pain associated with Canker Sores

  • Warnings

    Do not use this product for more than 7 days unless directed by a dentist or doctor. 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.

    Do not exceed recommended dosage.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 tablets a day, as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side on the sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the tablet 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 tablet before it dissolves. In case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the tablet. • children under 5 years, ask a doctor.

  • Other information

    store in a cool, dry place.

  • Inactive ingredients

    annatto, carbomer homopolymer type a, citrus oil, hydroxypropyl cellulose, magnesium chloride, povidone K30, povidone K90, silicon dioxide, xylitol

  • Questions or comments?

    833-362-2763 or consumeraffairs@doc-brands.com

  • PRINCIPAL DISPLAY PANEL

    Canker Cover 4ct Packaging

  • INGREDIENTS AND APPEARANCE
    DENTEMP CANKER COVER 
    canker cover tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73653-212
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorpink (ONE SIDE PINK, ONE SIDE WHITE) Scoreno score
    ShapeROUNDSize10mm
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73653-212-044 in 1 CARTON02/02/2023
    1NDC:73653-212-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02202/02/2023
    Labeler - DOC Brands (081254601)