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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Canker Cover 1 Count

Outer Packet Labeling

Canker Cover 1 Count Packet

Active ingredient: (per each patch)

Menthol 2.5 mg

Purpose

Oral Pain Reliever

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

Warnings:

Keep out of reach of children.

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.

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

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)

Revised: 12/2015
Document Id: 26921ec2-016d-331e-e054-00144ff88e88
Set id: 25de07eb-8232-6663-e054-00144ff88e88
Version: 4
Effective Time: 20151210
 
DenTek Oral Care, Inc.