Label: SPARKLE FRESH ANTICAVITY- sodium fluoride paste, dentifrice

  • NDC Code(s): 53329-082-21, 53329-082-92, 53329-082-93, 53329-082-94
  • Packager: Medline Industries, Inc.
  • 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 05/10

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

  • Active ingredient

    Sodium Fluoride (0.15% w/v of Fluoride Ion)

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  • Purpose

    Anticavity toothpaste

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  • Uses

    aids in the prevention of dental cavities

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  • Warnings

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

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

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  • 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 yrs. of age in good brushing and rinsing habits (to minimize swallowing)
    • Supervise children as necessary until capable of using without supervision
    • Children under 2 yrs. of age: Consult a dentist or physician
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  • Inactive ingredients

    Cellulose Gum, Disodium Phosphate, FD&C Blue No. 1, Flavor, Glycerin, Hydrated Silica, PEG 6, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water.

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  • Package/Label Principal Display Panel

    SparkleFresh Fluoride Toothpaste

    SparkleFresh Fluoride Toothpaste

    SparkleFresh

    Medline

    Fluoride Toothpaste

    REF NONTP85DS

    Net Wt 0.85 oz (24 g)

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  • INGREDIENTS AND APPEARANCE
    SPARKLE FRESH ANTICAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53329-082
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C BLUE NO. 1  
    GLYCERIN  
    HYDRATED SILICA  
    POLYETHYLENE GLYCOL 300  
    SODIUM LAURYL SULFATE  
    SACCHARIN SODIUM  
    SORBITOL  
    TITANIUM DIOXIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-082-93 24 g in 1 TUBE
    2 NDC:53329-082-94 78 g in 1 TUBE
    3 NDC:53329-082-21 42.5 g in 1 TUBE
    4 NDC:53329-082-92 17 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 04/01/2008
    Labeler - Medline Industries, Inc. (025460908)
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