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DenTek Canker Cover by DenTek Oral Care, Inc.

Medically reviewed on December 11, 2017

Dosage form: patch, extended release
Ingredients: MENTHOL 2.5mg in 194.85mg
Labeler: DenTek Oral Care, Inc.
NDC Code: 60630-091

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.

Canker Cover 1 Count

Outer Packet Labeling

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 AdministrationTRANSMUCOSALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.5 mg  in 194.85 mg
Inactive Ingredients
Ingredient NameStrength
SEA SALT10 mg  in 194.85 mg
CARBOMER 93456 mg  in 194.85 mg
POVIDONE44 mg  in 194.85 mg
XYLITOL65 mg  in 194.85 mg
HYDROXYPROPYL CELLULOSE (TYPE E)14 mg  in 194.85 mg
CITRUS MEDICA FRUIT2 mg  in 194.85 mg
COLLOIDAL SILICON DIOXIDE1.45 mg  in 194.85 mg
MAGNESIUM STEARATE0.4 mg  in 194.85 mg
Packaging
#Item CodePackage Description
1NDC:60630-091-041 DOSE PACK in 1 PACKET
1NDC:60630-091-012.5 mg in 1 DOSE PACK
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/FEIOperations
DenTek Oral Care, Inc.153818646relabel(60630-091)

 
DenTek Oral Care, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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