Label: MORNING FRESH- sodium monofluorophosphate paste

  • 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 April 11, 2013

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  • Active Ingredient

    Sodium Monofluorophosphate 0.76 %

  • Purpose: Anticavity

    Use

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

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

  • 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.
  • Indications and Usage

    • The prevention of dental cavities.
  • Warnings

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

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

  • Principal Display Panel

    Toothpaste.jpg

    Toothpaste

  • INGREDIENTS AND APPEARANCE
    MORNING FRESH 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-171-0143 g in 1 TUBE
    2NDC:67777-171-0278 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/08/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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