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Rembrandt Intense Stain (Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.)

Available Formats

Dosage Form Package Information Links
PASTE, DENTIFRICE 2.8 g in 1 PACKET (42002-440-01) Label Information
PASTE, DENTIFRICE 1 TUBE in 1 CARTON (42002-440-03) > 85 g in 1 TUBE Label Information

Complete Rembrandt Intense Stain Information

  • SPL UNCLASSIFIED SECTION

    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®
    + ActiShieldâ„¢

    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

  • INGREDIENTS AND APPEARANCE
    REMBRANDT INTENSE STAIN   BRILLIANT MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-440
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 (UNII: K679OBS311)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42002-440-03 1 in 1 CARTON
    1 85 g in 1 TUBE
    2 NDC:42002-440-01 2.8 g in 1 PACKET
    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)