Label: ALEGRIA NEO- silicon dioxide, allantoin paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 70406-020-01, 70406-020-02 - Packager: Seowangmo Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 3, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: D-Sorbitol Solution, Aqua, Polyethylene Glycol 1500, Mica, Concentrated Glycerin, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, Peppermint Oil, Anetol, Sophora Extract, Grapefruit Seed Extract, Xylitol, Glucosyl Stevia, L-Menthol, Hydroxyapatite, Eucalyptus Extract, Sage Extract, Chamomile Extract, Aloe Extract, Glycyrrhiza Extract Powder, Argentum
- 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 NEO
silicon dioxide, allantoin paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70406-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 2.80 g in 20 g Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.008 g in 20 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Xylitol (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70406-020-02 1 in 1 CARTON 10/01/2017 1 NDC:70406-020-01 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2017 Labeler - Seowangmo Corporation (689605288) Registrant - Seowangmo Corporation (689605288) Establishment Name Address ID/FEI Business Operations Seowangmo Corporation 689605288 manufacture(70406-020)