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 10, 2015

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

View All Sections
  • Outer Packet Labeling

    Canker Cover 1 Count Packet

  • ACTIVE INGREDIENT

    Active ingredient: (per each patch)

    Menthol 2.5 mg

  • PURPOSE

    Purpose

    Oral Pain Reliever

  • INDICATIONS & USAGE

    Uses: for the relief of pain associated with: . canker sores . mouth sores

  • KEEP OUT OF REACH OF CHILDREN

    Warnings:

    Keep out of reach of children.

  • WARNINGS

    Warnings:

    If irritation, pain or redness worsens, if swelling, rash or fever develops, or if sore mouth symptoms persist

    for 7 days, see your doctor or dentist.

  • DOSAGE & ADMINISTRATION

    Directions for use:adults and children 5 years of age and older

    The sore should be dry (pat with tissue) if 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 dissolving. Do not remove the patch before it dissolves. Consult your dentist or doctor before using.

    In case of discomfort, the patch may be removed by gently peeling it from the sides with your finger while

    washing with warm water.

    ​​​

  • INACTIVE INGREDIENT

    Inactive ingredients: carbomer homopolymer type a, polyvinyl pyrrolidone, xylitol, hydroxypropyl cellulose, silicon dioxide, carmallite TM​(mineral salt), citrus oil, annatto.

  • 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
    SEA SALT (UNII: 87GE52P74G) 10 mg  in 194.85 mg
    CARBOMER 934 (UNII: Z135WT9208) 56 mg  in 194.85 mg
    POVIDONE (UNII: FZ989GH94E) 44 mg  in 194.85 mg
    XYLITOL (UNII: VCQ006KQ1E) 65 mg  in 194.85 mg
    HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT) 14 mg  in 194.85 mg
    CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON) 2 mg  in 194.85 mg
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1.45 mg  in 194.85 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 0.4 mg  in 194.85 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-091-041 in 1 PACKET12/01/2015
    1NDC:60630-091-012.5 mg in 1 DOSE PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/11/2015
    Labeler - DenTek Oral Care, Inc. (153818646)
    Registrant - DenTek Oral Care, Inc. (153818646)
    Establishment
    NameAddressID/FEIBusiness Operations
    DenTek Oral Care, Inc.153818646relabel(60630-091)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!