Label: DAWNMIST- toothpaste paste, dentifrice
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NDC Code(s):
65517-2005-0,
65517-2005-1,
65517-2005-2,
65517-2005-3, view more65517-2005-4, 65517-2005-5
- Packager: Dukal LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 25, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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 minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAWNMIST
toothpaste paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65517-2005 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CALCIUM CARBONATE (UNII: H0G9379FGK) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC) METHYLPARABEN (UNII: A2I8C7HI9T) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65517-2005-0 17 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 2 NDC:65517-2005-1 24 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 3 NDC:65517-2005-2 43 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 4 NDC:65517-2005-3 78 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 5 NDC:65517-2005-4 134 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 6 NDC:65517-2005-5 181 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 03/25/2024 Labeler - Dukal LLC (791014871)