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]

Outer Packet Labeling

ACTIVE INGREDIENT

Active ingredient: (per each patch)

Menthol 2.5 mg

PURPOSE

Purpose

Oral Pain Reliever

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

Warnings:

Keep out of reach of children.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60630-091-04	1 in 1 PACKET	12/01/2015
1	NDC: 60630-091-01	2.5 mg in 1 DOSE PACK; Type 1: Convenience Kit of Co-Package

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)

Registrant - DenTek Oral Care, Inc. (153818646)

Establishment
Name	Address	ID/FEI	Business Operations
DenTek Oral Care, Inc.		153818646	relabel(60630-091)