Label: NAVI AMAZON PROPOL- sodium monofluorophosphate paste

  • 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.

Drug Label Information

Updated 02/13

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  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Purpose: Anticavity

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years old

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  • INDICATIONS & USAGE

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

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

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  • WARNINGS

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

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  • INACTIVE INGREDIENT

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

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  • DOSAGE & ADMINISTRATION

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

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  • INGREDIENTS AND APPEARANCE
    NAVI AMAZON PROPOL 
    sodium monofluorophosphate silicon dioxide paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55526-0001
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.228 g  in 120 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 1500 3.6 g  in 120 g
    GLYCERIN 6 g  in 120 g
    ERYTHRITOL 0.12 g  in 120 g
    XYLITOL 0.24 g  in 120 g
    STEVIOL 0.24 g  in 120 g
    CHITOSAN OLIGOSACCHARIDE 0.12 g  in 120 g
    LICORICE 0.12 g  in 120 g
    GREEN TEA LEAF 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)
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