Label: BRUSH BUDDIES TOTAL CARE ANTI-CAVITY PROTECTION- 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 September 22, 2023

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

View All Sections
  • Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.76%
    (0.13% w/v Fluoride ion)

  • Purpose

    Anticavity

  • Uses

    helps protect against cavities.

  • 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: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. 
    • do not swallow.
    • children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
    • children under 2 years of age: Consult a dentist or doctor.

  • Inactive ingredients

    Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (Cl 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

  • Questions or comments?

    call toll free 1-877-274-8358

  • SPL UNCLASSIFIED SECTION

    FRESH PEPPERMINT

    ANTI-CAVITY FLUORIDE TOOTHPASTE

    • FRESHENS BREATH
    • STRENGTHENS TEETH WITH ACTIVE FLUORIDE

    DESIGNED IN U.S.A.  •  MADE IN INDIA

    Brush Buddies®
    WWW.BRUSHBUDDIES.COM

    QUESTIONS OR COMMENTS?
    1-877-274-8358 TOLL FREE IN USA
    1-909-434-0911 INTERNATIONAL

    PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DISTRIBUTED BY ASHTEL STUDIOS INC.
    ONTARIO, CALIFORNIA 91761

  • Packaging

    Brush Buddies-078

  • INGREDIENTS AND APPEARANCE
    BRUSH BUDDIES TOTAL CARE ANTI-CAVITY PROTECTION 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-078
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT (Fresh peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-078-011 in 1 BOX09/07/2023
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02109/07/2023
    Labeler - Ashtel Studios, Inc. (148689180)
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!