DENTEK CANKER COVER- menthol patch, extended release 
DenTek Oral Care, Inc.

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.

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DenTek Canker Cover 60630-091

Active ingredient (per each patch)

Menthol 2.5 mg

Purpose

Oral pain reliever

Uses

for the temporary relief of pain associated with: 

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

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

DenTek
CANKER COVER
CANKER SORE PATCH
6 COUNT

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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60630-091-026 in 1 CARTON11/11/2015
1NDC:60630-091-012.5 mg in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35611/11/2015
Labeler - DenTek Oral Care, Inc. (153818646)

Revised: 6/2018
Document Id: 313aab8e-ea7b-4758-95ce-b214917355b4
Set id: dccdb4ef-203f-4c9b-85b4-a8a061c5656d
Version: 4
Effective Time: 20180622
 
DenTek Oral Care, Inc.