Label: PLUS WHITE COFFEE DRINKERS WHITENING- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL

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 ingredients

    Sodium Monofluorophosphate (0.15% w/v fluoride ion)

    Purpose

    Anticavity whitening toothpaste

  • Use

    Aids in the removal of stains and prevention of dental decay.

  • Warnings

     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.

    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 drink coffee - 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

    Sorbitol, Water (Aqua), Hydrated Silica, Dicalcium Phosphate, Glycerin, Sodium Lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin.

  • Questions or comments?

    Call Toll Free1-800-595-6230 - www.pluswhite.com

  • Package Labeling:

    PlusWhiteCoffee-BoxPlusWhiteCoffee-Tube

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE COFFEE DRINKERS WHITENING 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7224
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-7224-31 in 1 PACKAGE06/12/2010
    1100 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/12/2010
    Labeler - CCA Industries, Inc. (106771041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(61543-7224)
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