Dentek Canker Cover
FDA Label NDC 60630-091

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dentek Oral Care, Inc. for the product Dentek Canker Cover (NDC 60630-091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding outer packet labeling, indications & usage, otc - keep out of reach of children, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Outer Packet Labeling

Canker Cover 1 Count Packet (260101a 1count 072115 01)

Canker Cover 1 Count Packet (260101a 1count 072115 01)

Indications & Usage

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

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.

​​​

* Please review the disclaimer below.