Rembrandt Intense Stain Brilliant Mint

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 2.4mg in 1g
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-440

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.

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)

REMBRANDT INTENSE STAIN   BRILLIANT MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-440
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Hydrated Silica 
Water 
Glycerin 
Sorbitol 
Sodium Pyrophosphate 
Titanium Dioxide 
Sodium Lauroyl Sarcosinate 
Carboxymethylcellulose Sodium 
Lauryl Glucoside 
Cocamidopropyl Betaine 
Saccharin Sodium Dihydrate 
Sucralose 
Packaging
#Item CodePackage Description
1NDC:42002-440-031 TUBE (TUBE) in 1 CARTON
185 g in 1 TUBE
2NDC:42002-440-012.8 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 03/2012
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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