Label: PLUS PLUS WHITE SMOKERS 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 23, 2020

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  • Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.83% (0.11% fluoride ion)   

    Purpose

    Anticavity whitening toothpaste

  • Use

    aids in the removal of stains and prevention of dental decay

  • Warnings

    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

    • 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 ingredients

    water (aqua), sorbitol, hydrated silica, dicalcium phosphate, glycerin, sodium lauryl sulfate, flavor, PVM/MA copolymer, cellulose gum, titanium
    dioxide, trisodium phosphate, sodium saccharin, blue 1 (CI 42090), yellow 5 (CI 19140).

  • Questions or comments?

     Call Toll Free 1-800-595-6230 • www.pluswhite.com

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    PLUS PLUS WHITE SMOKERS WHITENING 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7236
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    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:61543-7236-31 in 1 BOX03/15/2019
    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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