Label: MORNING FRESH- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-174-01, 67777-174-02 - Packager: Dynarex Corporation
- 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 May 14, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose: Anticavity
- Inactive Ingredient
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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.
- Indications and Usage
- Warnings
- Keep out of reach of children.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MORNING FRESH
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-174 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.2 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) CALCIUM CARBONATE (UNII: H0G9379FGK) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POTASSIUM NITRATE (UNII: RU45X2JN0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-174-01 43 g in 1 TUBE 2 NDC:67777-174-02 78 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/14/2014 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)
