Label: ALEGRIA NEO- silicon dioxide, allantoin paste, dentifrice
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
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated November 3, 2017
If you are a consumer or patient please visit this version.
- ACTIVE 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
- KEEP OUT OF REACH OF CHILDREN
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
INGREDIENTS AND APPEARANCE
silicon dioxide, allantoin paste, dentifrice
Product 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)