Active Ingredient
Sodium Fluoride (0.243%) ...Anticavity
Rembrandt Intense Stain Paste, Dentifrice
FDA Label NDC 66923-373
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ranir Llc for the product Rembrandt Intense Stain (NDC 66923-373). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
Aids in the prevention of dental cavities.
Warnings
Keep out of reach of children under 6 years of age.
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.
Directions
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.
Other Information
• Store at Room Temperature
• do not use if inner foil is torn, cut or missing.
Inactive Ingredients
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?
Email [email protected], or call 800-548-3663
Distrubuted byr Ranir, LLC, Grand Rapids, MI 49512
Recent Major Changes
Directions: updated use instructions 7/2/2019
Pdp
REMBRANDT
WHITENING TOOTHPASTE WITH FLUORIDE
Mint
NET WT 3.5 oz (99.2 g)
I
INTENSE
STAIN
25x MORE STAIN REMOVED IN 1 WEEK*
STRENGTHENS & RESTORES ENAMEL
SPECIALLY FORMULATED TO WHITEN DEEPLY WITH PROVEN INGREDIENTS
MICROPOLISHERS
A unique blend effectively whitens by removing a tough stains
FLUORIDE
to actively strengthen and restore enamel
Care for the Smile you Love
Learn more at www.rembrandt.com
*When used with REMBRANDT Whitening Toothbrush or REMBRANDT Sonic Whitening Toothbrush.
Individual results may vary.
* Please review the disclaimer below.
