NAVI AMAZON PROPOL- sodium monofluorophosphate paste 
EQ Maxon Corp.

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.


Active Ingredients: Silicon Dioxide 16%, Sodium Monofluorophosphate 0.19%

Purpose: Anticavity

Keep out of reach of children under 6 years old

- Supervise children as necessary until being capable of using without supervision

- Instruct children under 6 years old in good brushing and rinsing habits

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

Inactive Ingredients: Propolis Extracts, Silica, Chitosan, Sorbitol Solution, Licorice Extracts, Xylitol

- Brush teeth twice daily or after each meal as directed by a dentist or doctor

Box Label

sodium monofluorophosphate silicon dioxide paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55526-0001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) 3.6 g  in 120 g
GLYCERIN (UNII: PDC6A3C0OX) 6 g  in 120 g
ERYTHRITOL (UNII: RA96B954X6) 0.12 g  in 120 g
XYLITOL (UNII: VCQ006KQ1E) 0.24 g  in 120 g
STEVIOL (UNII: 4741LYX6RT) 0.24 g  in 120 g
CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64) 0.12 g  in 120 g
LICORICE (UNII: 61ZBX54883) 0.12 g  in 120 g
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.12 g  in 120 g
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55526-0001-1 120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/2013
Labeler - EQ Maxon Corp. (557821534)
Name Address ID/FEI Business Operations
EQ Maxon Corp. 557821534 manufacture(55526-0001)

Revised: 2/2013
Document Id: 2124abe4-54f9-49f7-90ac-605880db7be8
Set id: 622d4f43-6a97-4990-a239-0ef187d9b365
Version: 1
Effective Time: 20130226
EQ Maxon Corp.