Label: BEEPROPOLIS - sodium monofluorophosphate paste, dentifrice 

  • NDC Code(s): 58964-101-01
  • Packager: Sinhwa Life Health Co Ltd
  • 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 07/13

If you are a consumer or patient please visit this version.

  • 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

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  • ACTIVE INGREDIENT

    Active Ingredients

    Sodium monofluorophosphate

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  • PURPOSE

    Purpose

    Anticaries

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Uses - Aids in the prevention of cavities

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  • 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


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  • 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.

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  • INGREDIENTS AND APPEARANCE
    BEEPROPOLIS 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58964-101
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 100 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPOLIS WAX  
    .ALPHA.-TOCOPHEROL  
    STEVIOSIDE  
    XYLITOL  
    SILICON DIOXIDE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    XANTHAN GUM  
    SORBITOL  
    POLYETHYLENE GLYCOL 4000  
    COCAMIDOPROPYL BETAINE  
    CITRUS PARADISI SEED  
    PEPPERMINT OIL  
    RACEMENTHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58964-101-01 1 in 1 CARTON
    1 180 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 07/01/2013
    Labeler - Sinhwa Life Health Co Ltd (688492682)
    Establishment
    Name Address ID/FEI Business Operations
    Sinhwa Life Health Co Ltd 688492682 manufacture(58964-101)
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