Label: SODIUM FLUORIDE paste, dentifrice

  • NDC Code(s): 67239-0226-0
  • Packager: Safco Dental Supply 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 March 24, 2023

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  • Active ingredient:

    Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)

  • Purpose:

    Anti-cavity

  • Use:

    Helps protect against cavities

  • Warning:

    KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    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 a physician.

    Children 2 to 6 years

    Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)

    Children under 2 years

    Ask a dentist or a physician

  • Other ingredients:

    Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum and/or Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Tetra Sodium Pyrophosphate, Glycerin, Color: FD&C Blue #1

    Package date and batch number on crimp.

  • Principal Display Panel – 24 g Box Label

    Quantum Fresh
    FLUORIDE TOOTHPASTE

    Quantum

    a safco company

    800-328-8213

    www.QuantumLabs.com

    Fluoride Toothpaste

    Reorder # 826-0001

    Net Wt. 0.85 oz (24 g)

    Expiration Date:

    2 years from date
    packed.

    NDC 67239-0226-0

    Made in India

    Principal Display Panel – 24 g Box Label
  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0226
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67239-0226-024 g in 1 TUBE; Type 0: Not a Combination Product04/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/24/2023
    Labeler - Safco Dental Supply LLC (020417380)
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