Dental Plus Fresh Mint Flavor

Manufacturer
tropical degil cosmetics industries ltd
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:36

Label at a glance#

ProductDental Plus Fresh Mint Flavor
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.8% (1000 ppm F)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Ask a dentist before use if you have

OTC - ASK DOCTOR SECTION

bleeding or redness lasting more than 2 weeks, pain, swelling, pus, loose teeth, or more spacing between teeth. These may be signs of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Water, sorbitol, calcium carbonate, silica, sodium lauryl sulphate, flavor, cellulose gum, sodium saccharin, sodium benzoate, benzoic acid.

Prinicipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dental plus fresh mint flavor

anticavity fluoride toothpaste

Net Wt 5.1 oz - 145 g

Front PanelFront Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048117sodium monofluorophosphate 0.8 % ToothpastePSN1
1048117sodium monofluorophosphate 0.008 MG/MG ToothpasteSCD1
1048117sodium monofluorophosphate 0.0081 MG/MG ToothpasteSY1
1048117sodium monofluorophosphate 0.8 % ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62685-218-032024-01-30C16284748780-11030e365-6db8-111a-e063-dadaa90a10e2Dental Plus Fresh Mint Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62685-218-03Dental Plus Fresh Mint Flavor145 g in 1 TUBEPASTE1451
62685-218-03Dental Plus Fresh Mint Flavor1 in 1 BOXPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62685-218DENTAL PLUS FRESH MINT FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE [TROPICAL DEGIL COSMETICS INDUSTRIES LTD]1Legacy NDC, 2 package rows20210227_bc092e50-b7fe-5aa8-e053-2a95a90aa9dc.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
62685-21862685-218-03

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
bc092e50-b7ff-5aa8-e053-2a95a90aa9dcbc092e50-b7fe-5aa8-e053-2a95a90aa9dc2021-02-23Exact identifier
spl id: bc092e50-b7ff-5aa8-e053-2a95a90aa9dc
spl set id: bc092e50-b7fe-5aa8-e053-2a95a90aa9dc

Reported adverse events (FAERS/openFDA)#

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