Label: PLUS WHITE XTRA- 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 August 13, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.83% (0.11% fluoride ion)

    Purpose

    Anticavity whitening toothpaste

  • Use

    aids in the prevention of dental cavities and removal of stains

  • Warnings

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

    If more than used for burshing is accidentally swallowed, get medical helo 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

  • Questions or comments?

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

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE XTRA 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7237
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-7237-31 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!