Dentemp Canker Cover

Manufacturer
DOC Brands
Effective date
2023-12-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:51

Label at a glance#

ProductDentemp Canker Cover
Active ingredientMENTHOL
Label structure11 sections

Dosage and administration

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 f...

Storage and handling

Other information store in a cool, dry place.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (per each tablet)

Menthol 2.5 mg

PURPOSE

OTC - PURPOSE SECTION

Purpose

Oral Pain Reliever

Indications for Use

INDICATIONS & USAGE SECTION

Indications for the temporary relief of pain associated with Canker Sores

PREGNANCY OR BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional

before use

WARNINGS

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

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.

DIRECTIONS

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

STORAGE

STORAGE AND HANDLING SECTION

Other information store in a cool, dry place.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients annato, carbomer homopolymer type a, citrus oil, hydroxypropyl

cellulose, magnesium chloride, povidone K30, povidone K90,silicon dioxide, xylitol

QUESTIONS

OTC - QUESTIONS SECTION

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

DENTEMP CANKER COVER PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dentemp Canker Cover CartonDentemp Canker Cover Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73653-211-06Dentemp Canker Cover150 mg in 1 BLISTER PACKTABLET, EXTENDED RELEASE1505
73653-211-07Dentemp Canker Cover6 in 1 CARTONTABLET, EXTENDED RELEASE65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73653-211DENTEMP CANKER COVER (CANKER COVER) TABLET, EXTENDED RELEASE [DOC BRANDS]5Legacy NDC, 2 package rows20231219_9e62378f-d267-dade-e053-2995a90a5211.zip

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
73653-21173653-211-06, 73653-211-07

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
0cbfdca6-de92-3e69-e063-6394a90a8f1d9e62378f-d267-dade-e053-2995a90a52112023-12-17WarningsExact identifier
spl id: 0cbfdca6-de92-3e69-e063-6394a90a8f1d
spl set id: 9e62378f-d267-dade-e053-2995a90a5211

Reported adverse events (FAERS/openFDA)#

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