Label: OLOGY FLUORIDE- 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.
Updated March 21, 2013
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- Active Ingredients
- adults and children 12 years and older: brush teeth thoroughly, preferably after each meal, or at least twice a day, or as directed by your dentist. do not swallow.
- children under 6 years of age: to minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
- children under 2 years of age: ask a dentist or physician.
- Inactive ingredients
- KEEP OUT OF REACH OF CHILDREN
- Principal Display Panel
INGREDIENTS AND APPEARANCE
sodium monofluorophosphate paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2008 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CALCIUM CARBONATE (UNII: H0G9379FGK) XYLITOL (UNII: VCQ006KQ1E) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ZINC CITRATE (UNII: K72I3DEX9B) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white (Fluoride) Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-2008-01 133 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/21/2013 Labeler - Walgreens (008965063)