Label: MORNING FRESH- sodium fluoride paste

  • NDC Code(s): 67777-175-01, 67777-175-02, 67777-175-10, 67777-175-11, view more
    67777-175-12, 67777-175-13
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL

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 December 1, 2022

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  • Active Ingredient

    Sodium Monofluorophosphate 0.76 %

  • Purpose: Anticavity

    Use

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

    Calcium carbonate, Carboxymethylcellulose sodium, Flavour, Methylparaben, Polyethyene glycol 400, Propylparaben, Saccharin sodium, Silicon dioxide, Sodium benzoate, Sodium lauryl sulphate, Sodium pyrophosphate, Sodium silicate, Sorbitol, Titanium dioxide, Water

  • 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

    Dynarex Morning Fresh Toothpaste

    Morning Fresh.jpg

    Morning Fresh

  • INGREDIENTS AND APPEARANCE
    MORNING FRESH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION76 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-175-11144 in 1 CASE10/14/2014
    1NDC:67777-175-101 in 1 BOX
    1NDC:67777-175-0143 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67777-175-13144 in 1 CASE10/14/2014
    2NDC:67777-175-121 in 1 BOX
    2NDC:67777-175-0278 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/14/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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