Label: PLUS WHITE SMOKERS WHITENING- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 26, 2019

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  • 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 INGREDIENT

    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, Yellow 5

  • QUESTIONS

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

  • Principal Display Panel -Tube 3.5 oz

    Plus+White
    THE SMOKER'S WHITENING 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 - Carton 3.5 oz

    Principal Display Panel - Carton 3.5 ozPlus + White 

    The Smokers Whitening 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

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE SMOKERS WHITENING 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1554
    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)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-1554-31 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(61543-1554)
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