REMBRANDT WHITENING  MINT INTENSE- sodium fluoride paste, dentifrice 
Johnson & Johnson Consumer Inc.

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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REMBRANDT® WHITENING TOOTHPASTE WITH FLUORIDE, INTENSE STAIN® mint

Drug Facts

Active ingredient

Sodium Fluoride 0.243% (w/w)
(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 amount used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older:

Other information

Store at Room Temperature

Inactive ingredients

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

Questions or comments?

call toll-free 800-548-3663 or 215-273-8755 (collect)

Distributed by:
JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 99.8 g Tube Carton

REMBRANDT®

I

INTENSE

STAIN®

WHITENING TOOTHPASTE WITH FLUORIDE

Removes Stains & Restores Enamel

mint

NET WT 3.52 oz (99.8g)

PRINCIPAL DISPLAY PANEL - 99.8 g Tube Carton
REMBRANDT WHITENING   MINT INTENSE
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0217
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Hydrated Silica (UNII: Y6O7T4G8P9)  
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Sodium Lauryl Sarcosinate (UNII: 5PGH842FAU)  
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
Lauryl Glucoside (UNII: 76LN7P7UCU)  
Povidone, Unspecified (UNII: FZ989GH94E)  
Xanthan Gum (UNII: TTV12P4NEE)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0217-31 in 1 CARTON12/01/2015
199.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2016
Document Id: ac0095b4-024b-4cb4-84c7-f6ec6747cd02
Set id: 9cd6d302-1638-4448-a937-06122c869a4d
Version: 2
Effective Time: 20161005
 
Johnson & Johnson Consumer Inc.