Rembrandt Intense Stain

Manufacturer
Ranir LLC
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:16

Label at a glance#

ProductRembrandt Intense Stain
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferably after each meal or at least 2 times a day, or as directed by a dentist or doctor. 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride (0.243%)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than amount used for brushing is accidentally swallowed, seek 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 (for at least 1 minute), preferably after each meal or at least 2 times a day, or as directed by a dentist or doctor.

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.

Other information

OTHER SAFETY INFORMATION

  • Store at 20°-25°C (68°-77°F).
  • Do not use if inner foil is torn, cut or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrated Silica, Water, Sorbitol, Tetrapotassium Pyrophosphate, Flavor, Titanium Dioxide, Sodium Lauroyl Sarcosinate, Cellulose Gum, Lauryl Glucoside, PVP, Sodium Sulfate, Cocamidopropyl Betaine, Xanthan Gum, Sodium Saccharin, Sucralose.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Email consumercare@rembrandt.com, or call 800-548-3663.

Distributed by Ranir, LLC,

Grand Rapids, MI 49512

©2018 Ranir, LLC 80102AB

SPL UNCLASSIFIED SECTION

Directions: updated use instructions 7/2/2019

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

I INTENSE STAIN®

REMBRANDT

WHITENING TOOTHPASTE WITH FLUORIDE

Mint

25x MORE STAIN REMOVED IN 1 WEEK

STRENGTHENS & RESTORES ENAMEL

NET WT 3.5 OZ (99.2 g)

rembrandt-intense-stain-carton
rembrandt-intense-stain-carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66923-373-01Rembrandt Intense Stain99.2 g in 1 TUBEPASTE, DENTIFRICE99.23
66923-373-02Rembrandt Intense Stain1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66923-373REMBRANDT INTENSE STAIN (SODIUM FLUORIDE) PASTE, DENTIFRICE [RANIR LLC]3Current NDC, Legacy NDC, 2 package rows20241127_55dcd063-5661-35aa-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66923-37366923-373-01, 66923-373-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
ndc (package): 66923-373-02
ndc (package): 66923-373-01
ndc (product): 66923-373
ndc11 (package): 66923037302
ndc11 (package): 66923037301
spl id: 492c5426-1082-421b-afae-a3286466683f
spl set id: 55dcd063-5661-35aa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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