DENTEK CANKER COVER- menthol patch, extended release

DenTek Canker Cover by

Drug Labeling and Warnings

DenTek Canker Cover by is a Otc medication manufactured, distributed, or labeled by DenTek Oral Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DENTEK CANKER COVER 
menthol patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60630-091
Route of Administration	TRANSMUCOSAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg  in 194.85 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60630-091-02	6 in 1 CARTON	11/11/2015
1	NDC: 60630-091-01	2.5 mg in 1 DOSE PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	11/11/2015

Labeler - DenTek Oral Care, Inc. (153818646)