FDA.reportPublic FDA data

Rembrandt

Manufacturer
Ashtel Studios, Inc
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:01

Label at a glance#

ProductRembrandt
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Monofluorophosphate 0.76%

OTC - PURPOSE SECTION

Purpose: Anticavity

INDICATIONS & USAGE SECTION

Use: Aids in the prevention of dental cavities.

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 2 years of age & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children under 6 years of age : Use a pea-sized amount and instruct 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. Do not swallow.

INACTIVE INGREDIENT SECTION

Inactive ingredients: CALCIUM CARBONATE, SORBITOL, TREATED WATER, SILICA, SODIUM LAURYL SULPHATE, FLAVOR, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE, TETRA SODIUM PYROPHOSPHATE, BENZYL ALCOHOL, SODIUM SACCHARIN, PROPYLPARABEN.

SPL UNCLASSIFIED SECTION

LICENSED BY RANIR, LLC. ALL RIGHTS RESERVED.      MADE IN INDIA
DIST. BY: ASHTEL STUDIOS, INC., ONTARIO, CA 91761 • COMMENTS OR QUESTIONS?
1-877-274-8358 TOLL FREE IN U.S.A. • 1-909-434-0911 INTERNATIONAL

Q

QUICK CLEAN®

TOOTHPASTE WITH FLUORIDE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
70108-031-012024-01-30C16284748780-11030e365-3ac5-111a-e063-dadaa90a10e2REMBRANDT ® TOOTHPASTE WITH FLUORIDE
70108-031-022024-01-30C16284748780-11030e365-3ac5-111a-e063-dadaa90a10e2REMBRANDT ® TOOTHPASTE WITH FLUORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-031-01Rembrandt10 g in 1 TUBEPASTE, DENTIFRICE101
70108-031-02Rembrandt20 g in 1 TUBEPASTE, DENTIFRICE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-031REMBRANDT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC]1Legacy NDC, 2 package rows20191215_cd780a97-ef82-4b15-9b96-f78e808501e4.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-03170108-031-01, 70108-031-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CALCIUM CARBONATEH0G9379FGKIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM SILICATEIJF18F77L3IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
BENZYL ALCOHOLLKG8494WBHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
599120b2-01f4-49cf-9b4f-fd74e0a13224cd780a97-ef82-4b15-9b96-f78e808501e42019-12-09WarningsExact identifier
spl id: 599120b2-01f4-49cf-9b4f-fd74e0a13224
spl set id: cd780a97-ef82-4b15-9b96-f78e808501e4

Reported adverse events (FAERS/openFDA)#

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