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.
Updated May 25, 2010
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- Active ingredient
Sodium Fluoride (0.15% w/v of Fluoride Ion)Close
aids in the prevention of dental cavitiesClose
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.
- 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
- 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.Close
- Package/Label Principal Display Panel
SparkleFresh Fluoride Toothpaste
Net Wt 0.85 oz (24 g)Close
- INGREDIENTS AND APPEARANCE
SPARKLE FRESH ANTICAVITY
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-082 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) 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)