Label: PLUS WHITE EXTRA 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% (0.15% 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

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

  • Directions 

    • adults and children 2 years and older
    • Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician
    • to minimize swallowing for children under the age of 6, use a pea size amountandsupervisebrushinguntil good habitsare established
    • children under 2 years of ask a dentistor physician
  • INACTIVE INGREDIENT

    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

    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

  • INGREDIENTS AND APPEARANCE
    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)
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