DenTemp Canker Cover- canker cover tablet, extended relief

Manufacturer
Team Technologies, Inc
Effective date
2021-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:44:32

Label at a glance#

ProductDenTemp Canker Sore Single Dose
Active ingredientMENTHOL
Label structure11 sections

Storage and handling

Other information store in a cool, dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (per each tablet)

Menthol 2.5 mg

INDICATIONS & USAGE SECTION

Indications and Usage

For the temporary relief of pain associated with canker sores

WARNINGS SECTION

Warnings

Do not use this product for more than 7 days unless directed by a dentist or doctor.

Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days

irritation, pain or redness worsens swelling, rash or fever develops

Do not exceed recommended dosage.

WARNINGS

Keep out of reach of children. In case of accidental overdose, get medical help or contact a

Poison Control Center (1-800-222-1222) right away.

PREGNANCY OR BREASTFEEDING
If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional - before use

INSTRUCTIONS FOR USE SECTION

Directions .adults and children 5 years of age and older, apply up to 3 tablets per day,

as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side on

the sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between the

cheek and gum or near the teeth or lip) break the tablet along the score and use half. Some

discomfort may occur during the first few minutes, but will quickly subside, followed by hours of

soothing relief. 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 tablet before it dissolves. In

case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while

washing with warm water. Do not use any instrument to remove the tablet.

.children under 5 years, ask a doctor

STORAGE AND HANDLING SECTION

Other information store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients annato, carbomer homopolymer type a, citrus oil, hydroxypropyl - cellulose, magnesium chloride, povidone K30, povidone K90,silicon dioxide, xylitol

OTC - QUESTIONS SECTION

Questions or comments? 833-363-2763 or consumeraffairs@doc-brands.com

DOSAGE & ADMINISTRATION SECTION

Directions .adults and children 5 years of age and older, apply up to 3 tablets per day,

as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side on

the sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between the

cheek and gum or near the teeth or lip) break the tablet along the score and use half. Some

discomfort may occur during the first few minutes, but will quickly subside, followed by hours of

soothing relief. 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 tablet before it dissolves. In

case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while

washing with warm water. Do not use any instrument to remove the tablet.

.children under 5 years, ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose,get medical help or contact a

Poison Control Center (1-800-222-1222) right away.

OTC - PURPOSE SECTION

Purpose

Oral Pain Reliever

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67659-160-072023-01-30C16284748780-1f386c649-d176-0266-e053-dadaa90a7c1aDenTemp Canker Cover- canker cover tablet, extended relief

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67659-16067659-160-07
73653-211

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c2dcf032-66e2-6854-e053-2a95a90ab640beed8392-2281-b8be-e053-2995a90aef9f2021-05-21WarningsExact identifier
spl id: c2dcf032-66e2-6854-e053-2a95a90ab640
spl set id: beed8392-2281-b8be-e053-2995a90aef9f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.