Label: DAWNMIST FLUORIDE TOOTH- sodium fluoride paste, dentifrice
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NDC Code(s):
70766-015-01,
70766-015-02,
70766-015-03,
70766-015-04, view more70766-015-05, 70766-015-06
- Packager: Yangzhou SION Commodity Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 29, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Active ingredients
SODIUM FLUORIDE 0.22%(0.10 w/v Fluoride ion)
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- Uses
- Warnings
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Directions
- Do not swallow, supervise children as necessary until capable of using without supervision. Instruct children under 12 years of age in good brushing and rinsing habits (to minimizing swallowing).
- Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a doctor.
- Children under 6 years of age: Do not use unless directed by a doctor or dentist.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAWNMIST FLUORIDE TOOTH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-015 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) CALCIUM CARBONATE (UNII: H0G9379FGK) HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70766-015-01 5 in 1 CARTON 04/29/2024 1 144 in 1 BOX 1 17 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70766-015-02 5 in 1 CARTON 04/29/2024 2 144 in 1 BOX 2 24 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70766-015-03 144 in 1 BOX 04/29/2024 3 43 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:70766-015-04 144 in 1 BOX 04/29/2024 4 78 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:70766-015-05 60 in 1 BOX 04/29/2024 5 135 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:70766-015-06 48 in 1 BOX 04/29/2024 6 181.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/04/2024 Labeler - Yangzhou SION Commodity Co.,Ltd (546806042) Registrant - Yangzhou SION Commodity Co.,Ltd (546806042) Establishment Name Address ID/FEI Business Operations Yangzhou SION Commodity Co.,Ltd 546806042 manufacture(70766-015)
