Label: PLUS WHITE XTRA WHITENING- sodium monofluorophosphate paste

  • 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 September 24, 2020

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  • Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.884% (0.15% w/v Fluoride ion)                   

    Purpose

    Anticavity whitening toothpaste

  • ​Use

       Aids in the prevention of dental cavities and removal of stains

  • Warnings


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

    Keep out of reach of children under 6 years of age

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

  • 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 6, use a pea-sized amount and supervise brushing until good habits are established
    • children under 2 years ask a dentist or physician.
  • Inactive ingredients

    Hydrated Silica, Sorbitol, Water (Aqua), Dicalcium Phosphate, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Titanium  Dioxide, 

    Trisodium Phosphate, PVM/MA Copolymer, Sodium Saccharin, Blue 1 (CI 42090).

  • QUESTIONS

    Questions or comments? Call Toll Free 1-800-595-6230 - www.pluswhite.com

  • Package Labeling:

    PlusWhiteBox1PlusWhiteTube1

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE XTRA WHITENING 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7243
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-7243-31 in 1 BOX06/11/2010
    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 finalpart35506/11/2010
    Labeler - CCA Industries, Inc. (106771041)
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