REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING  FRESH MINT- sodium fluoride mouthwash 
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 Mouthwash
Fresh Mint

Drug Facts

Active ingredient

Sodium fluoride (0.02%)

Purpose

Anticavity

Use

  • aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

  • if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 12 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • pour 10 milliliters (2 teaspoons)
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other information

  • store at 20°-25°C (68°-77°F)
  • do not use if printed safety band is missing, cut or torn

Inactive ingredients

water, sorbitol, propylene glycol, hydrogen peroxide, PEG-40 hydrogenated castor oil, flavor, sodium phosphate, disodium phosphate, poloxamer 407, sodium saccharin, calcium disodium EDTA

Questions?

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 - 474 mL Bottle Label

INTRODUCING
D
DEEPLY WHITE™
+ Peroxide

REMBRANDT®
FLUORIDE MOUTHWASH DESIGNED FOR SUPERIOR WHITENING

Deeply Whitens & Restores Enamel
fresh mint

IMPORTANT: READ DIRECTIONS FOR PROPER USE
Net Contents 16 fl oz (474 mL)

Principal Display Panel - 474 mL Bottle Label
REMBRANDT DEEPLY WHITE PLUS PEROXIDE WHITENING   FRESH MINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-442
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Polyethylene Glycol 2000 (UNII: HAF0412YIT)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Sodium Phosphate (UNII: SE337SVY37)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Edetate Calcium Disodium Anhydrous (UNII: 8U5D034955)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-442-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/201207/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/201207/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 7/2016
Document Id: c5d0a96b-258b-4210-97ce-1338171941e8
Set id: 0c8d98fa-76b3-4a2a-8828-56d32d04db79
Version: 2
Effective Time: 20160701
 
Johnson & Johnson Consumer Inc.