REMBRANDT WHITENING MINT INTENSE- sodium fluoride paste, dentifrice

Rembrandt Whitening by

Drug Labeling and Warnings

Rembrandt Whitening by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

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

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

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, Cocamidopropyl Betaine, Xanthan Gum, Sucralose, Sodium Saccharin

Questions or comments?

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

REMBRANDT®

I

INTENSE

STAIN®

WHITENING TOOTHPASTE WITH FLUORIDE

Removes Stains & Restores Enamel

mint

NET WT 3.52 oz (99.8g)

INGREDIENTS AND APPEARANCE

REMBRANDT WHITENING   MINT INTENSE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0217
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Hydrated Silica (UNII: Y6O7T4G8P9)
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Sorbitol (UNII: 506T60A25R)
Sodium Pyrophosphate (UNII: O352864B8Z)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium Lauryl Sarcosinate (UNII: 5PGH842FAU)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Lauryl Glucoside (UNII: 76LN7P7UCU)
Povidone, Unspecified (UNII: FZ989GH94E)
Xanthan Gum (UNII: TTV12P4NEE)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sucralose (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0217-3	1 in 1 CARTON	12/01/2015
1		99.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/01/2015

Labeler - Johnson & Johnson Consumer Inc. (002347102)