Dentemp Canker Cover

Manufacturer
DOC Brands
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:58

Label at a glance#

ProductDentemp Canker Cover
Active ingredientMENTHOL
Label structure11 sections

Dosage and administration

• adults and children 5 years of age and older, apply up to 3 tablets a 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, ...

Storage and handling

store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredient (per each tablet)

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5 mg

Purpose

OTC - PURPOSE SECTION

Ora pain reliever

Indications

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with Canker Sores

Warnings

WARNINGS SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use.

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

• adults and children 5 years of age and older, apply up to 3 tablets a 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.

Other information

STORAGE AND HANDLING SECTION

store in a cool, dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

annatto, carbomer homopolymer type a, citrus oil, hydroxypropyl cellulose, magnesium chloride, povidone K30, povidone K90, silicon dioxide, xylitol

Questions or comments?

OTC - QUESTIONS SECTION

833-362-2763 or consumeraffairs@doc-brands.com

8ct Canker Cover

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Canker Cover 8ctCanker Cover 8ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2628246menthol 2.5 MG Buccal TabletPSN2
2628246menthol 2.5 MG Buccal TabletSCD2

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
73653-210-01Dentemp Canker Cover1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
73653-210-08Dentemp Canker Cover8 in 1 CARTONTABLET, EXTENDED RELEASE82

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
73653-21073653-210-01, 73653-210-08

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
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
ndc (package): 73653-210-08
ndc (package): 73653-210-01
ndc (product): 73653-210
ndc11 (package): 73653021008
ndc11 (package): 73653021001
spl id: 47e23f4e-d4a7-7af1-e063-6394a90a2f05
spl set id: 2e7fbf9d-553c-c7bf-e063-6294a90a5f79

Reported adverse events (FAERS/openFDA)#

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