Label: NAVI AMAZON PROPOL- sodium monofluorophosphate paste
- NDC Code(s): 55526-0001-1
- Packager: EQ Maxon Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 Ingredients: Silicon Dioxide 16%, Sodium Monofluorophosphate 0.19%Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children under 6 years oldClose
- INDICATIONS & USAGE
- Supervise children as necessary until being capable of using without supervision
- Instruct children under 6 years old in good brushing and rinsing habitsClose
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right awayClose
- INACTIVE INGREDIENT
Inactive Ingredients: Propolis Extracts, Silica, Chitosan, Sorbitol Solution, Licorice Extracts, XylitolClose
- DOSAGE & ADMINISTRATION
- Brush teeth twice daily or after each meal as directed by a dentist or doctorClose
- INGREDIENTS AND APPEARANCE
NAVI AMAZON PROPOL
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 SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.228 g in 120 g 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 Packaging # 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) Establishment Name Address ID/FEI Business Operations EQ Maxon Corp. 557821534 manufacture(55526-0001)