Label: REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING FRESH MINT- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 42002-617-01
  • Packager: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 16, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium Monofluorophosphate 0.884% w/w (0.0.15% w/v fluoride)

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  • Purpose

    Anticavity

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  • Use

    aids in the prevention of dental cavities

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  • Warnings

    • Stop use and ask a doctor if oral irritation or tooth sensitivity occurs

    • Keep out of reach of children under 12 years of age.
    • If more than used brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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  • Directions

    • Adults and children 12 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
    • supervise children as necessary until capable of using without supervision
    • children under 12 years of age: ask a dentist or doctor
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  • Other information

    • store at 20° - 25°C (68° – 77° F)
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  • Inactive ingredients

    glycerin, hydrated silica, urea peroxide, aluminum hydroxide, modified food starch, flavor, sodium citrate, propylene glycol, cocamidopropyl betaine, papain, sodium lauryl sulfate, carbomer, sodium saccharin, calcium disodium EDTA

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  • Questions or comments?

    1-800-548-3663, www.rembrandt.com

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 74 g Tube Carton

    INTRODUCING
    REMBRANDT®
    D
    DEEPLY WHITE™
    + Peroxide

    PEROXIDE TOOTHPASTE FORMULATED FOR SUPERIOR WHITENING

    Whitens Deeper* & Restores Enamel
    fresh mint

    FLUORIDE TOOTHPASTE

    NET WT 2.6 oz (74g)

    Principal Display Panel - 74 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING   FRESH MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-617
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Sodium Monofluorophosphate 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrated silica (UNII: Y6O7T4G8P9)  
    Carbamide Peroxide (UNII: 31PZ2VAU81)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Papain (UNII: A236A06Y32)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
    Edetate Calcium Disodium Anhydrous (UNII: 8U5D034955)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42002-617-01 1 in 1 CARTON
    1 74 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 03/16/2012
    Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)
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