Label: ADVANCED WHITENING ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • 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 July 19, 2017

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

View All Sections
  • Drug FactsActive ingredient

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity toothpaste

  • Uses

    aids in the prevention of cavities

  • 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.

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

  • Directions

    • adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
    • do not swallow
    • to minimize swallowing, use a pea-sized amount in children under 6 years old
    • supervise children's brushing until good habits are established
    • children under 2 yrs: ask a dentist before use.
  • Inactive ingredients

    calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

  • Advanced Whitening Anticavity product label

    Personal Care™

    Advanced Whitening Anitcavity Fluoride Toothpaste

    FRESH MINT

    Fights Tarter Build-up

    NET WT 6.4 OZ. (181 G)

    Free Soft Toothrush

    Distributed by:
    Personal Care Products, LLC
    Troy, Michigan 48084 U.S.A.
    Made in China

    PC AdvWhite

  • INGREDIENTS AND APPEARANCE
    ADVANCED WHITENING ANTICAVITY FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9223
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1000 mg  in 181 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9223-61 in 1 BOX07/24/2017
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/24/2017
    Labeler - Personal Care Products, LLC (966155082)
    Registrant - Personal Care Products, LLC (966155082)
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!