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
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 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)
