FDA Label for Dentek Canker Cover

View Indications, Usage & Precautions

Dentek Canker Cover Product Label

The following document was submitted to the FDA by the labeler of this product Dentek Oral Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

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


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