PLUS WHITE EXTRA WHITENING- sodium monofluorophosphate gel, 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 Extra Whitening Gel 

Active Ingredient



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

Purpose

Anticavity Toothpaste

Uses

 Aids in the prevention of dental cavitites.

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 

Inactive ingredients Sorbitol, Hydrated Silica, Glycerin, Water (Purified), PEG 32, Flavor, Sodium lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Phosphate, Sodium Saccharin, Blue 1, yellow 10

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

Principal Display Panel -Tube 3.5 oz

Plus+White
Extra Whitening Gel TOOTHPASTE

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

Principal Display Panel -Tube 3.5 oz

Principal Display Panel - Carton 3.5 oz

Plus + White 

Extra Whitening Gel Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

Principal Display Panel - Carton 3.5 oz

PLUS WHITE EXTRA WHITENING 
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1606
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)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-1606-31 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, Inc. (106771041)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(61543-1606)

Revised: 12/2019
Document Id: 64660295-7970-46b2-b789-77c6a5f4ec53
Set id: 4e26d9cf-cee1-47dc-95bd-185ed29dfced
Version: 2
Effective Time: 20191226
 
CCA Industries, Inc.