Label: MORNING FRESH- sodium monofluorophosphate paste
- 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.
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- Active Ingredient
Sodium Monofluorophosphate 0.76 %Close
- Purpose: Anticavity
- 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, SorbitolClose
- Dosage and Administration
- 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.
- 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.Close
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
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)