Label: FARMASI WHITENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 74690-012-01, 74690-012-02
  • Packager: Farmasi US LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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

View All Sections
  • DRUG FACTS

  • ACTIVE INGREDIENTS

    Sodium Fluoride 0.24 % (0.15% w/v fluoride ion)

    PURPOSE

    Anticavity

  • USES

    Helps proctect teeth and prevents cavities. Whitens teeth by removing surface stains.

  • WARNINGS

    Keep out of reach of children

    under 6 years of age. If more than used for brushing in accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Adults and children 6 years of age and older: brush teeth thoroughly after meals of at least twice a day, or as directed by a dentist or physician.

  • INACTIVE INGREDIENTS

    Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca Alternifolia Leaf Oil, Panax Ginseng Root Extract, Aloe Juice/Aloe Barbadensis Leaf Juice, Salvadora Persica Bark/Root Extract.

  • Questions or Comments?

    info@farmasius.com Monday - Friday (9 a.m - 6 p.m.EST) 1 786 238 7338

  • 25g Package Labeling:

    25g Label25g Tube25g Inner Label

  • 112g Package Labeling:

    tubebox

  • INGREDIENTS AND APPEARANCE
    FARMASI WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74690-012
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SALVADORA PERSICA ROOT (UNII: 526M7ZU616)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74690-012-011 in 1 BOX04/15/2021
    1112 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:74690-012-021 in 1 BOX09/25/2021
    225 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/15/2021
    Labeler - Farmasi US LLC (113303351)
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!