NDC Code(s) : 42002-440-03, 42002-440-01
Packager : Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rembrandt Intense Stain Sodium Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42002-440
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride(UNII: 8ZYQ1474W7)
(Fluoride Ion - UNII:Q80VPU408O) 		Sodium Fluoride2.4 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 Lauroyl Sarcosinate(UNII: 632GS99618)
Carboxymethylcellulose Sodium(UNII: K679OBS311)
Lauryl Glucoside(UNII: 76LN7P7UCU)
Cocamidopropyl Betaine(UNII: 5OCF3O11KX)
Saccharin Sodium Dihydrate(UNII: SB8ZUX40TY)
Sucralose(UNII: 96K6UQ3ZD4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42002-440-031 in 1 CARTON
185 g in 1 TUBE
2NDC:42002-440-012.8 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 03/16/2012

PRINCIPAL DISPLAY PANEL

NEW! SUPERIOR STAIN REMOVAL®

REMBRANDT®
I
INTENSE STAIN®
+ ActiShield™

FLUORIDE TOOTHPASTE FORMULATED FOR SUPERIOR STAIN REMOVAL®

Removes Stains • Repels Future Stains • Restores Enamel

brilliant mint

NET WT 3.0 oz (85g)

Principal Display Panel - 85 g Tube Carton