Label: TEND ANTICAVITY- sodium monofluorophosphate gel

  • NDC Code(s): 78594-000-01, 78594-000-02
  • Packager: Tend, LLC
  • 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 June 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

    Aids in the prevention of dental cavities.

  • Warnings

    Keep out of reach of children

    under 6 years of age.If you swallow more than a pea-sized dollop, get medical help or contact a poison control center right away.

  • Directions

    • Adults and children 6 years of age and older: our dentists recommend applying a pea-sized dollop of toothpaste on a soft-bristled toothbrush. Brush teeth thoroughly for 2 minutes twice a day, and not more than 3 times a day, or as recommended by your dentist or  hysician. Minimize swallowing. 
    • Children under 6 years of age: consult a dentist or physician.
  • Inactive ingredients

    glycerin, water, calcium carbonate, hydrated silica, hydroxyapatite, xanthan gum, flavor, sodium lauroyl sarcosinate, benzyl alcohol, sodium bicarbonate

  • QUESTIONS

    (888) 818-3686 www.hellotend.com

  • Package Labeling:

    Outer PackageInner Package

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    TEND ANTICAVITY 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78594-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78594-000-011 in 1 CARTON01/01/2022
    196 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:78594-000-020.8 g in 1 TUBE; Type 1: Convenience Kit of Co-Package01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2022
    Labeler - Tend, LLC (117113952)
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!