PLUS WHITE EXTRA WHITENING- sodium monofluorophosphate paste, dentifrice 
CCA Industries LLC

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 Extra Whitening Toothpaste 

Active ingredient



Sodium Monofluorophosphate 0.83% (0.15% w/v fluoride ion)               

Purpose

Anticavity whitening toothpaste

Use

Aids in the removal of stains and prevention of dental decay.

Warnings 

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

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

Directions 

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

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

Plus White Extra Whitening -Carton 3.5 oz

Plus+White Extra Whitening 

Fluoride Protection

Fluoride Anticavity toothpaste

NET WT. 3.5 oz (100G)

Plus White Extra Whitening -Carton 3.5 oz

Plus White Extra Whitening -Tube 3.5 oz

Plus +White Extra Whitening 

Fluoride Protection

NET WT 3.5 oz (100G)

Plus White Extra Whitening -Tube 3.5 oz

PLUS WHITE EXTRA WHITENING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1502
Route of AdministrationDENTAL
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)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
TRIBASIC SODIUM PHOSPHATE (UNII: A752Q30A6X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-1502-31 in 1 CARTON01/31/2018
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 finalpart35501/31/2018
Labeler - CCA Industries LLC (106771041)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(61543-1502)

Revised: 12/2019
Document Id: d741e08c-11d9-4756-bc79-228aab723371
Set id: e488a39b-eb29-40ed-abc6-b238b05eac29
Version: 2
Effective Time: 20191226
 
CCA Industries LLC