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

  • NDC Code(s): 73653-211-06, 73653-211-07
  • 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

    Active Ingredient (per each tablet)

    Menthol 2.5 mg

  • PURPOSE

    Purpose

    Oral Pain Reliever

  • Indications for Use

    Indications for the temporary relief of pain associated with Canker Sores

  • PREGNANCY OR BREASTFEEDING

    If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional

    before use

  • WARNINGS

    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.

  • Warnings

    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

    Directions .adults and children 5 years of age and older, apply up to 3 tablets per 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

  • STORAGE

    Other information store in a cool, dry place.

  • INACTIVE INGREDIENTS

    Inactive ingredients annato, carbomer homopolymer type a, citrus oil, hydroxypropyl

    cellulose, magnesium chloride, povidone K30, povidone K90,silicon dioxide, xylitol

  • QUESTIONS

    Questions or comments? 833-363-2763 or consumeraffairs@doc-brands.com

  • DENTEMP CANKER COVER PRINCIPAL DISPLAY PANEL

    Dentemp Canker Cover Carton

  • INGREDIENTS AND APPEARANCE
    DENTEMP CANKER COVER 
    canker cover tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73653-211
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 150 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    Product Characteristics
    Colorpink (one side pink, one side white) Scoreno score
    ShapeROUNDSize10mm
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73653-211-076 in 1 CARTON02/20/2020
    1NDC:73653-211-06150 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02202/20/2020
    Labeler - DOC Brands (081254601)