Label: PLUS WHITE WITH PEROXIDE- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 Fatcs

  • Active ingredient

    Sodium Monofluorophosphate 0.83% (0.11% w/v fluoride ion)                               

    Purpose

    Anticavity whitening toothpaste

  • Use

    aids in the prevention of dental cavities

  • WARNINGS

    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

    • adults and children 2 years and older
    • b rush 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:

    GLYCERIN, HYDRATED SILICA, PROPYLENE GLYCOL, SORBITOL, DICALCIUM PHOSPHATE, SODIUM LAURYL SULFATE, FLAVOR, UREA PEROXIDE, TITANIUM DIOXIDE, SODIUM CARBONATE, CALCIUM PEROXIDE, CARBOMER, SODIUM SACCHARIN, SODIUM BENZOATE.

  • Questions or comments?

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

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE WITH PEROXIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7233
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-7233-21 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 not finalpart35606/09/2010
    Labeler - CCA Industries, Inc. (106771041)
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