Label: REMBRANDT DEEPLY WHITE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 66923-258-01, 66923-258-02
  • Packager: Ranir LLC
  • 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 January 26, 2021

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  • Active ingredient

    Sodium Monofluorophosphate (0.884%)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warning

  • Keep out of reach of children under 6 years of age.

    If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older:
    Brush teeth thoroughly (for at least 1 minute), preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    Children under 6 years of age: Use a pea-sized amount and instruct 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: Consult a dentist or doctor. Do not swallow.

  • Other information

    Store at 20°– 25°C (68°– 77°F).

  • Inactive ingredients

     
    Calcium Pyrophosphate, Water, Glycerin, PEG-8, Flavor, Carbomer, Hydrogen Peroxide, Sodium Lauryl Sulfate, Sodium Saccharin, Potassium Hydroxide, Sucralose, Trisodium Ethylenediamine Disuccinate.
  • QUESTIONS OR COMMENTS?

    Email consumercare@rembrandt.com, or call 800-548-3663.

    Distributed by Ranir, LLC

    Grand Rapids, MI 49512

    ©2018 Ranir, LLC 81791

  • Principal Display Panel

    NEW & IMPROVED

    D DEEPLY WHITE® + Peroxide

    REMBRANDT®

    ANTICAVITY FLUORIDE TOOTHPASTE WITH PEROXIDE

    New! Peppermint

    3 SHADES WHITER IN 1 WEEK

    STRENGTHENS & RESTORES ENAMEL

    NOW WITH EVEN MORE!

    NET WT 3.5 OZ (99.2 g)

    rembrandt-carton
  • INGREDIENTS AND APPEARANCE
    REMBRANDT DEEPLY WHITE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-258
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION88.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-258-021 in 1 CARTON03/01/2019
    1NDC:66923-258-0199.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/01/2019
    Labeler - Ranir LLC (364567615)
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