PLUS WHITE- sodium monofluorophosphate paste, dentifrice 
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.

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Plus White Toothpaste with Peroxide

Active Ingredient

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

Purpose

Anticavity Toothpaste

Uses

 Aids in the prevention of dental decay.

Warnings

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

Keep out of the reach of children under 6 years of age.

Directions 

 This toothpaste is formulated for adults 18 and over who smoke tobacco

- It should not be utilized by children under 18 years old without consulting a dentist or physician
- Brush teeth thoroughly, preferably after each meal, or at least twice a day, or when new stains are apparent.

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 Free1-800-595-6230
- www.pluswhite.com

Principal Display Panel -Tube 2.0 oz

Plus+White
Plus White  TOOTHPASTE with Peroxide

Net Wt 2.0 oz (56.6G) - Fluoride Anticavity Toothpaste

Principal Display Panel -Tube 2.0 oz

Principal Display Panel -Tube 2.0 oz

Principal Display Panel - Carton 2.0 oz

Plus + White 

Plus White Toothpaste with Peroxide

NET WT 2.0 oz (56.6G) Fluoride Anticavity Toothpaste 

Principal Display Panel - Carton 2.0 oz

Principal Display Panel - Carton 2.0 oz

Principal Display Panel - Carton 2.0 oz

Principal Display Panel - Carton 2.0 oz

PLUS WHITE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1751
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.83 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-1751-31 in 1 CARTON05/22/2018
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/22/2018
Labeler - CCA Industries, Inc. (106771041)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(61543-1751)

Revised: 8/2018
Document Id: af060a95-bec3-4f9c-85c6-e98454637efb
Set id: 7581b27b-6acb-45b0-8804-b5dae3498931
Version: 1
Effective Time: 20180801
 
CCA Industries, Inc.