PLUS WHITE COFFEE- 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 Coffee Toothpaste

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 Sorbitol, Hydrated Silica, Water (Purified), Dicalcium Phosphate, Glycerin, PVM/MA Copolymer, Flavor, Sodium lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Blue 1, 

Questions or comments? Call Toll Free1-800-595-6230
- www.pluswhite.com

Principal Display Panel -Tube 3.5 oz

Plus+White
Plus White Coffee TOOTHPASTE

Net Wt 3.5 oz (100G) - Fluoride Anticavity Toothpaste

Principal Display Panel -Tube 3.5 oz

Principal Display Panel -Tube 3.5 oz

Principal Display Panel -Tube 3.5 oz

Principal Display Panel -Tube 3.5 oz
Principal Display Panel -Tube 3.5 oz

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 ozPlus + White 

Plus White Coffee Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 oz

Principal Display Panel - Carton 3.5 oz

PLUS WHITE COFFEE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1702
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)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
TRISODIUM DIPHOSPHATE (UNII: AR7OGW33N1)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-1702-31 in 1 CARTON06/30/2018
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 finalpart35506/30/2018
Labeler - CCA Industries, Inc. (106771041)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(61543-1702)

Revised: 12/2019
Document Id: 739b719f-e282-400b-b991-f9d995fa4d70
Set id: 1ae56900-5a10-481c-92bc-211de9c614bd
Version: 2
Effective Time: 20191224
 
CCA Industries, Inc.