NDC Code(s) : 42002-442-16
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rembrandt Deeply White Plus Peroxide Whitening Sodium Fluoride MOUTHWASH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42002-442
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride(UNII: 8ZYQ1474W7)
(Fluoride Ion - UNII:Q80VPU408O) 		Fluoride Ion0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Sorbitol(UNII: 506T60A25R)
Propylene Glycol(UNII: 6DC9Q167V3)
Hydrogen Peroxide(UNII: BBX060AN9V)
Polyethylene Glycol 2000(UNII: HAF0412YIT)
Hydrogenated Castor Oil(UNII: ZF94AP8MEY)
Sodium Phosphate(UNII: SE337SVY37)
Poloxamer 407(UNII: TUF2IVW3M2)
Saccharin Sodium(UNII: SB8ZUX40TY)
Edetate Calcium Disodium Anhydrous(UNII: 8U5D034955)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42002-442-16474 mL in 1 BOTTLE Type 0: Not a Combination Product16/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 03/16/2012 07/01/2018

PRINCIPAL DISPLAY PANEL

INTRODUCING
D
DEEPLY WHITE™
+ Peroxide

REMBRANDT®
FLUORIDE MOUTHWASH DESIGNED FOR SUPERIOR WHITENING

Deeply Whitens & Restores Enamel
fresh mint

IMPORTANT: READ DIRECTIONS FOR PROPER USE
Net Contents 16 fl oz (474 mL)

Principal Display Panel - 474 mL Bottle Label