PLUS WHITE WITH PEROXIDE- sodium monofluorophosphate paste 
CCA Industries, 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.

----------

Plus White With Peroxide

Drug Fatcs

Active ingredient

Sodium Monofluorophosphate 0.83% (0.11% w/v fluoride ion)                               

Purpose

Anticavity whitening toothpaste

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients:

GLYCERIN, HYDRATED SILICA, PROPYLENE GLYCOL, SORBITOL, DICALCIUM PHOSPHATE, SODIUM LAURYL SULFATE, FLAVOR, UREA PEROXIDE, TITANIUM DIOXIDE, SODIUM CARBONATE, CALCIUM PEROXIDE, CARBOMER, SODIUM SACCHARIN, SODIUM BENZOATE.

Questions or comments?

call Toll Free 1-800-595-6230 • www.pluswhite.com

Package Labeling:

Label4

PLUS WHITE WITH PEROXIDE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7233
Route of AdministrationDENTAL
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-7233-21 in 1 BOX03/15/2019
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/09/2010
Labeler - CCA Industries, Inc. (106771041)

Revised: 9/2020
Document Id: b000b6d8-f927-6cd8-e053-2a95a90a42f5
Set id: 8cee9e75-78c0-4af0-89f5-2ddb88ad6a78
Version: 4
Effective Time: 20200923
 
CCA Industries, Inc.