Label: MCKESSON FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 68599-0123-1, 68599-0123-2
  • Packager: McKesson Medical-Surgical
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 27, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Monofluorophosphate 0.76% (0.122% w/v of fluoride ion)

  • Purpose

    Anticavity

  • Use

    Helps protect against cavities.

  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 2 years of age and older:Brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.
    • Children under 6 years of age:Use a pea-sized amount to minimize swallowing and supervise child's brushing until good habits are established.
    • Children under 2 years of age:Ask a dentist or physician.
  • Inactive ingredients

    calcium carbonate, purified water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxy methyl cellulose, sodium benzoate, sodium saccharin

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 1.5 oz Case Label

    Mint
    Flavor

    McKESSON
    Fluoride Toothpaste

    1 Tube per Box, 1.5 oz
    144 Boxes Per Case

    Reorder No. 16-9571

    Principal Display Panel – 1.5 oz Case Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 1.5 oz Box Label

    Mint
    Flavor

    McKESSON
    Fluoride Toothpaste

    Net Wt. 1.5 oz. (43g)

    Principal Display Panel – 1.5 oz Box Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 1.5 oz Tube Label

    Mint
    Flavor

    McKESSON
    Fluoride Toothpaste

    Net Wt. 1.5 oz. (43g)

    Principal Display Panel – 1.5 oz Tube Label
  • INGREDIENTS AND APPEARANCE
    MCKESSON FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0123
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0123-1144 in 1 CARTON02/17/201206/01/2026
    11 in 1 BOX
    143 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68599-0123-2144 in 1 CARTON02/17/201206/01/2026
    21 in 1 BOX
    278 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/17/201206/01/2026
    Labeler - McKesson Medical-Surgical (023904428)
    Registrant - AmLion Toothpaste Mfg. Sdn. Bhd. (652244161)
    Establishment
    NameAddressID/FEIBusiness Operations
    AmLion652244161manufacture(68599-0123)
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