DAWNMIST GEL FLUORIDE- gel fluoride toothpaste gel, dentifrice

DawnMist Gel Fluoride by

Drug Labeling and Warnings

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

Drug Details [pdf]

DawnMist Gel 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.

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

Sorbitol, Hydrated Silica, Glycerin, Water, PEG-400, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Xanthan Gum, Sodium Saccharin

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2004-1

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2004-2

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2004-3

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

PRINCIPAL DISPLAY PANEL

DawnMist NDC: 65517-2004-0

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

INGREDIENTS AND APPEARANCE

DAWNMIST GEL FLUORIDE 
gel fluoride toothpaste gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-2004
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
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65517-2004-1	17 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2024
2	NDC: 65517-2004-0	78 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2024
3	NDC: 65517-2004-2	24 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2024
4	NDC: 65517-2004-3	43 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/01/2024

Labeler - Dukal LLC (791014871)