Active Ingredient
Sodium Monofluorophosphate (0.884%)
Rembrandt Deeply White Plus Peroxide Paste, Dentifrice
FDA Label NDC 66923-123
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 Deeply White Plus Peroxide (NDC 66923-123). 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, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, package/label principal display panel, 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.
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), preferable after each meal or at least twice 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
Store at 20° - 25°C (68°-77°F).
Inactive Ingredients
calcium pyrophosphate, water, glycerin, PEG-8, colloidal silicon dioxide, hydrogen peroxide, flavor, sodium lauryl sulfate, sodium saccharin, cellulose gum, xanthan gum, citric acid, sodium citrate, sucralose, trisodium ethylenediamine, PVP
Package/Label Principal Display Panel
D DEEPLY WHITE® + Peroxide
WHITER TEETH IN 3 DAYS
REMBRANDT®
ANTICAVITY FLUORIDE TOOTHPASTE WITH PEROXIDE
STRENGTHENS & RESTORES ENAMEL
Peppermint
NET WT 3.5 OZ (99.2 g)
Rembrandt-tym (Rembrandt Tym)
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