Label: REMBRANDT INTENSE STAIN- sodium fluoride paste, dentifrice

  • NDC Code(s): 66923-373-01, 66923-373-02
  • 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 27, 2021

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  • Active ingredient

    Sodium Fluoride (0.243%)

  • 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 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 2 times 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).
    •
    Do not use if inner foil is torn, cut or missing.
  • Inactive ingredients

    Glycerin, Hydrated Silica, Water, Sorbitol, Tetrapotassium Pyrophosphate, Flavor, Titanium Dioxide, Sodium Lauroyl Sarcosinate, Cellulose Gum, Lauryl Glucoside, PVP, Sodium Sulfate, Cocamidopropyl Betaine, Xanthan Gum, Sodium Saccharin, Sucralose.

  • QUESTIONS OR COMMENTS?

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

    Distributed by Ranir, LLC,

    Grand Rapids, MI 49512

    ©2018 Ranir, LLC 80102AB

  • SPL UNCLASSIFIED SECTION

    Directions: updated use instructions 7/2/2019

  • Principal Display Panel

    I INTENSE STAIN®

    REMBRANDT

    WHITENING TOOTHPASTE WITH FLUORIDE

    Mint

    25x MORE STAIN REMOVED IN 1 WEEK

    STRENGTHENS & RESTORES ENAMEL

    NET WT 3.5 OZ (99.2 g)

    rembrandt-intense-stain-carton
  • INGREDIENTS AND APPEARANCE
    REMBRANDT INTENSE STAIN 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-373
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION24.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-373-021 in 1 CARTON07/25/2016
    1NDC:66923-373-0199.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/25/2016
    Labeler - Ranir LLC (364567615)
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