Home > Drugs A-Z > Rembrandt Deeply White Plus Peroxide Whitening

Rembrandt Deeply White Plus Peroxide Whitening (Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.)

Available Formats

Dosage Form Package Information Links
MOUTHWASH 474 mL in 1 BOTTLE (42002-442-16) Label Information

Complete Rembrandt Deeply White Plus Peroxide Whitening Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Sodium fluoride (0.02%)


  • Purpose

    Anticavity


  • Use

    • aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children.

    • if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 12 years of age and older:

    • use twice a day after brushing your teeth with a toothpaste
    • pour 10 milliliters (2 teaspoons)
    • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • supervise children as necessary until capable of using without supervision
    • children under 12 years of age: consult a dentist or doctor

  • Other information

    • store at 20°-25°C (68°-77°F)
    • do not use if printed safety band is missing, cut or torn

  • Inactive ingredients

    water, sorbitol, propylene glycol, hydrogen peroxide, PEG-40 hydrogenated castor oil, flavor, sodium phosphate, disodium phosphate, poloxamer 407, sodium saccharin, calcium disodium EDTA


  • Questions?

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


  • SPL UNCLASSIFIED SECTION

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


  • PRINCIPAL DISPLAY PANEL - 474 mL Bottle Label

    INTRODUCING
    D
    DEEPLY WHITEâ„¢
    + Peroxide

    REMBRANDT®
    FLUORIDE MOUTHWASH DESIGNED FOR SUPERIOR WHITENING

    Deeply Whitens & Restores Enamel
    fresh mint

    IMPORTANT: READ DIRECTIONS FOR PROPER USE
    Net Contents 16 fl oz (474 mL)

    Principal Display Panel - 474 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING   FRESH MINT
    sodium fluoride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-442
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Polyethylene Glycol 2000 (UNII: HAF0412YIT)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Sodium Phosphate (UNII: SE337SVY37)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Edetate Calcium Disodium Anhydrous (UNII: 8U5D034955)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42002-442-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/2012 07/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 03/16/2012 07/01/2018
    Labeler - Johnson & Johnson Consumer Inc. (002347102)