DAWNMIST- toothpaste paste, dentifrice

DawnMist by

Drug Labeling and Warnings

DawnMist by is a Otc medication manufactured, distributed, or labeled by Dukal LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DawnMist Fluoride Toothpaste

ACTIVE INGREDIENT

Sodium Fluoride 0.22%

PURPOSE

Anticavity

INDICATIONS & USAGE

Aids in the prevention of dental cavities.

WARNINGS

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

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

Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2005-0

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2005-1

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2005-2

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2005-3

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2005-4

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

4.75 OZ. (134 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2005-5

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

6.4 OZ. (181 g)

INGREDIENTS AND APPEARANCE

DAWNMIST 
toothpaste paste, dentifrice

Product 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)