Your browser does not support JavaScript! NAVI AMAZON PROPOL (SODIUM MONOFLUOROPHOSPHATE SILICON DIOXIDE) PASTE [EQ MAXON CORP.]
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NAVI AMAZON PROPOL (sodium monofluorophosphate silicon dioxide) paste
[EQ Maxon Corp.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

NAVI AMAZON PROPOL 
sodium monofluorophosphate silicon dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55526-0001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.228 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 15003.6 g  in 120 g
GLYCERIN6 g  in 120 g
ERYTHRITOL0.12 g  in 120 g
XYLITOL0.24 g  in 120 g
STEVIOL0.24 g  in 120 g
CHITOSAN OLIGOSACCHARIDE0.12 g  in 120 g
LICORICE0.12 g  in 120 g
GREEN TEA LEAF0.12 g  in 120 g
Packaging
#Item CodePackage Description
1NDC:55526-0001-1120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2013
Labeler - EQ Maxon Corp. (557821534)
Establishment
NameAddressID/FEIBusiness Operations
EQ Maxon Corp.557821534manufacture(55526-0001)

Revised: 02/2013
Document Id: 2124abe4-54f9-49f7-90ac-605880db7be8
Set id: 622d4f43-6a97-4990-a239-0ef187d9b365
Version: 1
Effective Time: 20130226
 
EQ Maxon Corp.

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