Label: ASTONEA -SODIUM FLUORIDE- sodium floride paste, dentifrice

  • NDC Code(s): 77338-091-38
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • 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 December 4, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.22% w/w

  • Purpose

    Anticavity Toothpaste

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of the 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 immediately
  • Directions

    • Do not Swallow
    • Supervise children as necessary until capable of using without supervision
    • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
    • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    • Children under 6 years of age: Do not use unless directed by a dentist or physician
  • Other Information

    • Store at 59°-86°F (15°-30°C)
    • Avoid excessive heat
  • Inactive Ingredients

    Flavor, Glycerin, PEG-1500, Silica, Sodium Benzoate, Sodium Carboxymethyl Cellulose, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Tetra Sodium Pyrophosphate, Titanium Dioxide, Water

  • PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA -SODIUM FLUORIDE 
    sodium floride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-091
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-091-3843 g in 1 TUBE; Type 0: Not a Combination Product01/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/15/2015
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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