Label: BEEPROPOLIS- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 14, 2013

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Propolis extract, Vitamin E, Stevioside, Xylitol, Silicon Dioxide,

    Carboxymethylcellulose sodium, Xanthan Gum, D-Sorbitol solution,

    Polyethylene glycol 4000, Cocamidopropyl betaine, Grapefruit seed extract,

    Peppermint Oil, DL-Menthol, Water

  • ACTIVE INGREDIENT

    Active Ingredients

    Sodium monofluorophosphate

  • PURPOSE

    Purpose

    Anticaries

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • INDICATIONS & USAGE

    Uses - Aids in the prevention of cavities

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 6 years of age and older - Brush teeth thoroughly preferably after each meal or at least twice a day

    or as directed by a dentist or doctor

    Children under 12 years of age - To minimize swallowing, use a pea sized amount and supervise brushing

    until good habits are established

    Children under 5 years of age - Consult a dentist or doctor


  • WARNINGS

    Warnings

    Keep out of 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  right away.

    Do not Use if you are sensitive to bees or bee products.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    BEEPROPOLIS 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58964-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION100 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    RACEMENTHOL (UNII: YS08XHA860)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58964-101-011 in 1 CARTON
    1180 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/01/2013
    Labeler - Sinhwa Life Health Co Ltd (688492682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinhwa Life Health Co Ltd688492682manufacture(58964-101)
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