ALEGRIA- sodium monofluorophosphate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Seowangmo corporation

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Anticavity Use: Aids in the prevention of dental cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

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.
US E
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
Seowangmo corporation
ALEGRIA
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 40 6 -0 10
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM MO NO FLUO RO PHO SPHA TE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION
- UNII:Q8 0 VPU40 8 O)
FLUORIDE ION
0 .9 8 g in 130 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
GLYCERIN (UNII: PDC6 A3C0 OX)
PACKAG