ALEGRIA- sodium monofluorophosphate paste, dentifrice
Seowangmo corporation

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.

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ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.76%

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

Purpose: Anticavity

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 dental cavities

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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ALEGRIA
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70406-010
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.98 g in 130 g

Ingredient Name	Strength
Inactive Ingredients
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70406-010-01	130 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/02/2016

Labeler - Seowangmo corporation (689605288)

Registrant - Seowangmo corporation (689605288)

Name	Address	ID/FEI	Business Operations
Establishment
Seowangmo corporation		689605288	manufacture(70406-010)