FDA.reportPublic FDA data

Priyal

Manufacturer
Priyal Cosmetics
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:12

Label at a glance#

ProductPriyal
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Indications and uses

aids in the prevention of dental cavities

Dosage and administration

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor ■ children under 6 years of age: do not use unless directe...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor ■ children under 6 years of age: do not use unless directed by a doctor or dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose,Flavor, sodium saccharin, sodium methylparaben, sodium propylparaben

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Fact PanelDrug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72822-900-532022-01-28C16284748780-1d6a99b39-5c83-a426-e053-dadaa90af4c2Priyal Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72822-900-53Priyal43 g in 1 TUBEPASTE, DENTIFRICE431

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72822-900PRIYAL (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PRIYAL COSMETICS]1Legacy NDC, 1 package rows20200714_aa54fa9c-7e2d-8bab-e053-2995a90afaa7.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
72822-90072822-900-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
aa54f625-e021-f159-e053-2a95a90af976aa54fa9c-7e2d-8bab-e053-2995a90afaa72020-07-09WarningsExact identifier
spl id: aa54f625-e021-f159-e053-2a95a90af976
spl set id: aa54fa9c-7e2d-8bab-e053-2995a90afaa7

Reported adverse events (FAERS/openFDA)#

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