Label: SPARKLEFRESH FLOURIDE TOOTHPASTE- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 53329-083-21, 53329-083-92, 53329-083-93, 53329-083-94
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated June 16, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
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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 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
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
SPARKLEFRESH FLOURIDE TOOTHPASTE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-083 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM SILICATE (UNII: IJF18F77L3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CALCIUM CARBONATE (UNII: H0G9379FGK) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITOL (UNII: 506T60A25R) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-083-21 42.5 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2019 2 NDC:53329-083-92 17 g in 1 PACKET; Type 0: Not a Combination Product 08/01/2019 3 NDC:53329-083-93 24 g in 1 PACKET; Type 0: Not a Combination Product 08/01/2019 4 NDC:53329-083-94 78 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2007 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)