Label: DAWNMIST FLUORIDE- sodium fluoride paste
- NDC Code(s): 65517-2018-0
- Packager: Dukal LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 13, 2023
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- Official Label (Printer Friendly)
- DawnMist Fluoride Toothpaste
- Active Ingredient
- Purpose
- Use
- Warning:
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Directions
Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
Children under 6 years: To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
Children under 2 years: Ask a dentist or physician.
- Inactive Ingredients
- DawnMist Fluoride Toothpaste 0.6oz/17g (65517-2018-0)
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INGREDIENTS AND APPEARANCE
DAWNMIST FLUORIDE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65517-2018 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65517-2018-0 17 g in 1 TUBE; Type 0: Not a Combination Product 01/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/30/2014 Labeler - Dukal LLC (791014871)