Rembrandt Whitening

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2016-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:22:32

Label at a glance#

ProductRembrandt Whitening Mint Intense
Active ingredientSodium Fluoride
Label structure11 sections

Dosage and administration

adults and children 2 years of age and older: brush teeth thoroughly, 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 ...

Storage and handling

Store at Room Temperature Do not use if inner foil is torn, cut or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243% (w/w)
(0.15% w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If more than amount used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older:

  • brush teeth thoroughly, 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.

Other information

STORAGE AND HANDLING SECTION

Store at Room Temperature

  • 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, Cocamidopropyl Betaine, Xanthan Gum, Sucralose, Sodium Saccharin

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 800-548-3663 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 99.8 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REMBRANDT®

I

INTENSE

STAIN®

WHITENING TOOTHPASTE WITH FLUORIDE

Removes Stains & Restores Enamel

mint

NET WT 3.52 oz (99.8g)

PRINCIPAL DISPLAY PANEL - 99.8 g Tube Carton
PRINCIPAL DISPLAY PANEL - 99.8 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-021769968-0217-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
abb523b0-640d-4225-8dd4-112ff18c8e7c9cd6d302-1638-4448-a937-06122c869a4d2020-09-25WarningsExact identifier
spl set id: 9cd6d302-1638-4448-a937-06122c869a4d

Reported adverse events (FAERS/openFDA)#

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