Label: SPARKLEFRESH FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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  • Active ingredient

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity toothpaste

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children if

    If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.

  • Directions

    -adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician

    -instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)

    -supervise children as necessary until capable of using without supervision

    -children under 2 years of age: consult a dentist or physician

  • Inactive ingredients

    calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin,methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben

  • Label

    Entire Label

  • INGREDIENTS AND APPEARANCE
    SPARKLEFRESH FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-083(NDC:53329-083)
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83062-083-9324 g in 1 PACKET; Type 0: Not a Combination Product10/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/06/2023
    Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)
    Registrant - Team Technologies (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    IIMED MEDICAL MEXICANA S DE RL DE CV812894376relabel(83062-083) , repack(83062-083)
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