REMBRANDT INTENSE STAIN- sodium fluoride paste, dentifrice 
Ranir LLC

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.

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373 Rembrandt Intense Stain Mint Whitening Toothpaste

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

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
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)

Revised: 1/2021
Document Id: e0428891-ec04-4b79-831a-64df632b1287
Set id: 55dcd063-5661-35aa-e054-00144ff8d46c
Version: 2
Effective Time: 20210127
 
Ranir LLC