Label: SPARKLEFRESH FLUORIDE- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 83062-083-93
- Packager: IIMED MEDICAL MEXICANA S DE RL DE CV
- This is a repackaged label.
- Source NDC Code(s): 53329-083
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 6, 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
- Label
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INGREDIENTS AND APPEARANCE
SPARKLEFRESH FLUORIDE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83062-083(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) 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 Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83062-083-93 24 g in 1 PACKET; Type 0: Not a Combination Product 10/06/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 10/06/2023 Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376) Registrant - Team Technologies (192339703) Establishment Name Address ID/FEI Business Operations IIMED MEDICAL MEXICANA S DE RL DE CV 812894376 relabel(83062-083) , repack(83062-083)