ALEGRIA NEO- silicon dioxide, allantoin paste, dentifrice
Seowangmo Corporation

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.

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ACTIVE INGREDIENT

Active Ingredient: Dental Type Silica 14.0%, Aluminium Chlorohydroxy Allantoinate 0.04%

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

Purpose: Gum Care

WARNINGS

Warnings: If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of children under 6 years of age.

Use

Use: Aids in the prevention of gum care

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

Image of carton

ALEGRIA NEO
silicon dioxide, allantoin paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70406-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/01/2017

Labeler - Seowangmo Corporation (689605288)

Registrant - Seowangmo Corporation (689605288)

Name	Address	ID/FEI	Business Operations
Establishment
Seowangmo Corporation		689605288	manufacture(70406-020)