Rembrandt Deeply White + Peroxide Whitening Toothpaste Winter Mint

Drug Labeling and Warnings

Drug Details [pdf]

REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING  WINTER MINT- sodium monofluorophosphate 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 Deeply White + Peroxide Whitening Toothpaste
Winter Mint

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.884% w/w (0.0.15% w/v fluoride)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

  • Stop use and ask a doctor if oral irritation or tooth sensitivity occurs

  • Keep out of reach of children under 12 years of age.
  • If more than used brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older:
  • brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: ask a dentist or doctor

Other information

  • store at 20° - 25°C (68° – 77° F)

Inactive ingredients

glycerin, hydrated silica, urea peroxide, aluminum hydroxide, modified food starch, flavor, sodium citrate, propylene glycol, cocamidopropyl betaine, papain, sodium lauryl sulfate, carbomer, sodium saccharin, calcium disodium EDTA

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 74 g Tube Carton

INTRODUCING
REMBRANDT®
D
DEEPLY WHITE™
+ Peroxide
PEROXIDE TOOTHPASTE FORMULATED FOR SUPERIOR WHITENING

Whitens Deeper* & Restores Enamel
winter mint

FLUORIDE TOOTHPASTE

NET WT 2.6 oz (74g)

Principal Display Panel - 74 g Tube Carton
REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING   WINTER MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-616
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Hydrated silica (UNII: Y6O7T4G8P9)  
Carbamide Peroxide (UNII: 31PZ2VAU81)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Papain (UNII: A236A06Y32)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Edetate Calcium Disodium Anhydrous (UNII: 8U5D034955)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-616-011 in 1 CARTON03/16/201207/01/2016
174 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/201207/01/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: fc2a6f14-5f05-4349-ad40-d4cdc8fc913e
Set id: 42e9bfcd-3b55-4d49-857e-9a81e3b6d1eb
Version: 2
Effective Time: 20190111