Label: ESCOPINIO PHYTO ALPHA TOOTHPASTE- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 44781-447-81 - Packager: Zion Synthetic Fiber Corporation Limited
- 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 January 21, 2010
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Other Ingredients:
Water, Dicalcium Phosphodihydrate, Tocopheryl Acetate, Sodium Benzoate, d-Sorbitol, Sodium Carboxymethylcellulose, Silica, Monosodium Phosphate, Sodium Lauryl Sulfate, Monooleic Sorbate, Tetrasodium Pyrophosphate, Sodum Saccharin, Xylitol, Mentha (peppermint), Fragrance HF 30302, Sage Oil, Myrrh Extract, Cardamom Extract, Blue FCF #1, Yellow #4, Titanium Dioxide
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WHEN USING
Directions:
Adults and children 2 years and older:
Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by your dentist.
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: Ask a dentist or physician
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ESCOPINIO PHYTO ALPHA TOOTHPASTE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44781-447 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.912 g in 120 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44781-447-81 120 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/21/2010 Labeler - Zion Synthetic Fiber Corporation Limited (688011147) Registrant - Zion Synthetic Fiber Corporation Limited (688011147) Establishment Name Address ID/FEI Business Operations Zion Synthetic Fiber Corporation Limited 688011147 manufacture
