DENTEK CANKER COVER- menthol patch, extended release 
Bershtel Enterprises

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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Active Ingredient

menthol: 2.5 mg

Keep Out of Reach of Children Section

Warning: Keep out of reach of children.

Purpose Section

For Relief of pain associated with: canker sores & mouth sores.

Ask Doctor

Consult your dentist or doctor before using.

Indications & Usage

Adult and Children 5 year of age and older.

The sore should be dry (pat with tissue) is 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 disolving. DO NOT REMOVE PATCH BEFORE IT DISSOLVES.

Dosage & Administration

2.5 mg per patch

Questions section

Call us 800-4Dentek (433-6835) M-F 8am - 5am EST or email us at Info@Dentek.com

Warning Section

Keep out of reach of children. If irritation, pain, or redness worsens, if swelling, rash or fever develops, or if sore mouth systoms persists for 7 days, see your doctor or dentist.

Inactive Ingredients

  1. citrus medica fruit
  2. povidone
  3. colloidal silicon dioxide
  4. carbomer 934
  5. Xylitol
  6. Hydroxypropyl
  7. sea salt
  8. magnesium stearate

consumer box

DENTEK CANKER COVER 
menthol patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-0910
Route of AdministrationTRANSMUCOSAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 194.85 
Inactive Ingredients
Ingredient NameStrength
CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
CARBOMER 934 (UNII: Z135WT9208)  
POVIDONE (UNII: FZ989GH94E)  
HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT)  
SEA SALT (UNII: 87GE52P74G)  
XYLITOL (UNII: VCQ006KQ1E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Color    Score    
ShapeROUNDSize9mm
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10564-0910-21 in 1 CARTON; Type 0: Not a Combination Product12/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2015
Labeler - Bershtel Enterprises (066659129)

Revised: 12/2015
Document Id: 2668aa9c-571d-4aba-e054-00144ff8d46c
Set id: 2669183c-7a58-037e-e054-00144ff88e88
Version: 8
Effective Time: 20151204
 
Bershtel Enterprises