REMBRANDT CANKER SORE  MINT- sodium fluoride paste, dentifrice 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rembrandt Canker Sore Toothpaste
Mint

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.0.15% 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 used brushing is accidentally swallowed, get medical help 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 physician
  • Instruct children under 6 years of age 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: ask a dentist or doctor

Other information

  • store at (59° - 77°F)

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, flavor, titanium dioxide, cellulose gum, PVP, sodium saccharin, sucralose

Questions?

call 1-888-222-0182, weekdays

Distributed by: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 85g Tube Carton

REMBRANDT®
C
CANKER
SORE
WHITENING TOOTHPASTE WITH FLUORIDE
Specially Formulated for Canker Sores
Mint

NET WT 3.0 oz (85g)

Principal Display Panel - 85g Tube Carton
REMBRANDT CANKER SORE   MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-441
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-441-031 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/201208/01/2016
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 8/2012
Document Id: c2560f8d-6666-4f95-aadd-500d62da348c
Set id: d781dc6c-3932-4212-bdb1-e0ec041e34f8
Version: 2
Effective Time: 20120809
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.