REMBRANDT INTENSE STAIN  BRILLIANT MINT- sodium fluoride paste, dentifrice 
Johnson & Johnson Consumer 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 Intense Stain Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (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 (20° - 25°C)
  • do not use if inner foil is torn, cut or missing

Inactive ingredients

hydrated silica, water, glycerin, sorbitol, tetrasodium pyrophosphate, flavor, titanium dioxide, sodium lauryl sarcosinate, cellulose gum, lauryl glucoside, PVP, cocamidopropyl betaine, sodium saccharin, sucralose

Questions or comments?

US/Canada 1-800-548-3663, Outside US/Canada call collect 215-273-8755, www.rembrandt .com

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

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
REMBRANDT INTENSE STAIN   BRILLIANT MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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, UNSPECIFIED FORM (UNII: K679OBS311)  
Lauryl Glucoside (UNII: 76LN7P7UCU)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-440-031 in 1 CARTON03/16/201207/01/2016
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:42002-440-012.8 g in 1 PACKET; Type 0: Not a Combination Product03/16/201207/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/201207/01/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: e65f9236-1759-4d7d-b9f8-ec1c4ff327d0
Set id: 11df694e-1594-4eb4-9318-05d6bab51335
Version: 2
Effective Time: 20190111
 
Johnson & Johnson Consumer Inc.