Dental plus Extra Menta

Manufacturer
Tropical International Manufacturing Inc | Tropical Degil Cosmetics Industries LTD
Effective date
2010-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:52

Label at a glance#

ProductDental plus Extra Menta
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure11 sections

Dosage and administration

Adults and children 2 years of age and older Children 2 to 6 years Children under 2 years Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by dentist or physician. Use only a pea-sized amount and supervise child brushing and rinsing (to minimize swallowing) Ask a dentist or a physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.8% (1,000 ppmF)

Purpose

OTC - PURPOSE SECTION

anticavity

Use

INDICATIONS & USAGE SECTION

For cavity prevention and tooth protection.

Warnings

WARNINGS SECTION


Keep out of the 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.

SPL UNCLASSIFIED SECTION


Drug Facts (continued)

Dental plus Extra Menta 200 g

Directions

DOSAGE & ADMINISTRATION SECTION










Adults and children 2 years of age and older
Children 2 to 6 years

Children under 2 years
Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by dentist or physician.
Use only a pea-sized amount and supervise child brushing and rinsing (to minimize swallowing)
Ask a dentist or a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Calcium Carbonate, Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Sodium saccharin, Sodium Bicarbonate, Sodium Benzoate, Zinc Citrate

Questions? Comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-777-8767. Monday-Friday 9am-5pm

SPL UNCLASSIFIED SECTION

Made by Tropical Degil Cosmetics

Ind. Ltd. Kiryat Shmona, Israel for

Tropical International Cosmetics, Inc.

18 Stewart Street,

Brooklyn, NY 11207 USA

Made in Israel

PRINCIPAL DISPLAY PANEL - 7 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICAVITY FLUORIDE TOOTHPASTE

FIGHTS CAVITIES and TOOTH DECAY

Tropical DEGIL Dental plus EXTRA MENTA

NEW GIANT SIZE STAND UP TUBE

EXTRA REFRESHING MINT FLAVOR

NET WT. 7 OZ (200 G)

Principal Display Panel - 7 oz TubePrincipal Display Panel - 7 oz Tube

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62678-206-062019-10-21C16284748780-1956f9ecf-ca5c-621f-e053-dbdaa90a74adec24ea45-4599-43f8-ae16-e7f2399b9653

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62678-206-06Dental plus Extra Menta1 in 1 CARTONPASTE, DENTIFRICE11
62678-206-06Dental plus Extra Menta200 g in 1 TUBEPASTE, DENTIFRICE2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62678-206DENTAL PLUS EXTRA MENTA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TROPICAL INTERNATIONAL MANUFACTURING INC]1Legacy NDC, 2 package rows20100618_ec24ea45-4599-43f8-ae16-e7f2399b9653.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62678-20662678-206-06

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIB

Source Document#

Source XML · Source PDF

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
4d732bef-4ecc-41e4-8965-8ef07a330395ec24ea45-4599-43f8-ae16-e7f2399b96532010-05-19WarningsExact identifier
spl id: 4d732bef-4ecc-41e4-8965-8ef07a330395
spl set id: ec24ea45-4599-43f8-ae16-e7f2399b9653

Reported adverse events (FAERS/openFDA)#

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