ASTONEA -SODIUM FLUORIDE- sodium floride paste, dentifrice

ASTONEA -SODIUM FLUORIDE by

Drug Labeling and Warnings

ASTONEA -SODIUM FLUORIDE by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.22% w/w

Purpose

Anticavity Toothpaste

Use

aids in the prevention of dental cavities

Warnings

Keep out of the reach of children under 6 years of age!

• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

• Do not Swallow
• Supervise children as necessary until capable of using without supervision
• Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
• Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• Children under 6 years of age: Do not use unless directed by a dentist or physician

Other Information

• Store at 59°-86°F (15°-30°C)
• Avoid excessive heat

Inactive Ingredients

Flavor, Glycerin, PEG-1500, Silica, Sodium Benzoate, Sodium Carboxymethyl Cellulose, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Tetra Sodium Pyrophosphate, Titanium Dioxide, Water

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

INGREDIENTS AND APPEARANCE

ASTONEA -SODIUM FLUORIDE 
sodium floride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-091
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-091-38	43 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/15/2015

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)