Label: SODIUM FLUORIDE paste, dentifrice

  • NDC Code(s): 67239-0227-0
  • Packager: Safco Dental Supply LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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  • Active ingredient:

    Sodium Fluoride - 0.243 % (0.14 % 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, Aqua, Silica, PEG-32, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, Carbopol, Tetrasodium Pyrophosphate, Mica, FD&C Blue # 1, Titanium Dioxide

    Package date and batch number on crimp.

  • Principal Display Panel –

    Quantum Fresh kids
    FLUORIDE TOOTHPASTE

    Bubblegum
    flavored

    Quantum
    a safco company

    800-328-8213

    www.QuantumLabs.com

    Fluoride Toothpaste

    Reorder #826-0002

    Net Wt. 0.85 oz (24 g)

    Expiration Date:
    2 years from date
    packed.

    NDC 67239-0227-0

    Made in India

    C. No. DNH/COS/DNH/52

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0227
    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)  
    MICA (UNII: V8A1AW0880)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67239-0227-072 in 1 BOX12/24/2023
    124 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/24/2023
    Labeler - Safco Dental Supply LLC (020417380)
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