Label: ALEGRIA- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 70406-010-01 - Packager: Seowangmo 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 February 25, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: D-Sorbitol Solution, Silicon Dioxide, Dentaltype silica, Polyethylene Glycol 1500, Glycerin, Sodium Lauryl Sulfate, Carboxymethylcellulose Sodium, Sodium Benzoate, Allantonie Chlorohydroxy Aluminum, Aminocaproic Acid, Xylitol, Saccharin Sodium Hydrate, Licorice Extract, Sophora Extract, Aloevera Gel, Peppermint Oil, L-Menthol, Anethole, Carvone, Mica, Silver foil, Purified Water
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Use
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Directions
Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALEGRIA
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70406-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.98 g in 130 g Inactive Ingredients Ingredient Name Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70406-010-01 130 g in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/02/2016 Labeler - Seowangmo corporation (689605288) Registrant - Seowangmo corporation (689605288) Establishment Name Address ID/FEI Business Operations Seowangmo corporation 689605288 manufacture(70406-010)