Pro Care Flouride

Manufacturer
DILIGO HOLDINGS JOINT STOCK COMPANY
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:22

Label at a glance#

ProductPro Care Flouride
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.21%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Other information

SPL UNCLASSIFIED SECTION

Use at least 0.04 oz (1 g) of toothpaste. Close the cap after usage. Keep away from direct sunlight for a long time.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cellulose Gum, Hydrate Silica, Flavor, Mica, Organic psidium guajava fruit, PEG-32, Propolis Extract, Sodium Chloride, Sodium Lauryl Sulfate, Sodium Sarcharin, Sorbitol, Troxerutin, Water, Xylitol.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099038sodium fluoride 0.21 % ToothpastePSN1
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCD1
1099038sodium fluoride 0.21 % ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78989-001-012022-01-28C16284748780-1d6a99b39-931a-a426-e053-dadaa90af4c2Pro Care Flouride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78989-001-01Pro Care Flouride1 in 1 BOXGEL11
78989-001-01Pro Care Flouride185 g in 1 TUBEGEL1851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78989-001PRO CARE FLOURIDE (SODIUM FLUORIDE) GEL [DILIGO HOLDINGS JOINT STOCK COMPANY]1Legacy NDC, 2 package rows20200811_ac8a9fd0-5447-2ade-e053-2a95a90a36d9.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78989-00178989-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
ac8aa365-f122-366d-e053-2a95a90a0379ac8a9fd0-5447-2ade-e053-2a95a90a36d92020-08-10WarningsExact identifier
spl id: ac8aa365-f122-366d-e053-2a95a90a0379
spl set id: ac8a9fd0-5447-2ade-e053-2a95a90a36d9

Reported adverse events (FAERS/openFDA)#

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