Label: MORNING FRESH- sodium monofluorophosphate paste 

  • Label RSS
  • NDC Code(s): 67777-171-01, 67777-171-02
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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  • Active Ingredient

    Sodium Monofluorophosphate 0.76 %

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  • Purpose: Anticavity

    Use

    • Aids in the prevention of dental cavities.
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  • Inactive Ingredient

    Calcium carbonate, Carboxymethycellulose sodium, Flavour, Methylparaben sodium, Propylparaben sodium, Purified water, Saccharin sodium, Silicon dioxide, Sodium lauryl sulfate, Sorbitol

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  • Dosage and Administration

    Directions:

    • Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
    • Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
    • Children under 2 years Ask a dentist or physician.
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  • Indications and Usage

    • The prevention of dental cavities.
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  • Warnings

    • If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.
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  • Keep out of reach of children.

    Keep out of reach of children under 6 years of age.

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  • Principal Display Panel

    Toothpaste.jpg

    Toothpaste

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  • INGREDIENTS AND APPEARANCE
    MORNING FRESH 
    sodium monofluorophosphate paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67777-171
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL  
    SILICON DIOXIDE  
    CALCIUM CARBONATE  
    METHYLPARABEN SODIUM  
    PROPYLPARABEN SODIUM  
    SACCHARIN SODIUM  
    WATER  
    CARBOXYMETHYLCELLULOSE SODIUM  
    SODIUM LAURYL SULFATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-171-01 43 g in 1 TUBE
    2 NDC:67777-171-02 78 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 06/08/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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