ASTONEA -SODIUM FLUORIDE- sodium floride paste, dentifrice 
ASTONEA LABS PRIVATE LIMITED

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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astonea -sodium fluoride

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

Other Information

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

Principal Display and Drug Fact Panel

ASTONEA -SODIUM FLUORIDE 
sodium floride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-091
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-091-3843 g in 1 TUBE; Type 0: Not a Combination Product01/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/15/2015
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 12/2022
Document Id: ef052828-db6d-d7a8-e053-2995a90a9031
Set id: e69bc270-e909-1139-e053-2995a90a039b
Version: 2
Effective Time: 20221204
 
ASTONEA LABS PRIVATE LIMITED