DAWNMIST FLUORIDE- sodium fluoride paste

DAWNMIST FLUORIDE by

Drug Labeling and Warnings

DAWNMIST FLUORIDE by is a Otc medication manufactured, distributed, or labeled by DUKAL Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DawnMist Gel Fluoride Toothpaste

Active Ingredient

Sodium Fluoride 0.22%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warning:

Keep out of reach of children under 6 years of age

If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately

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 peas sized amount and supervisor brushing until good habits are established.

Children under 2 years: Ask a dentist or physician

Inactive Ingredient

Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin

Principal Display Panel - DawnMist Gel Fluoride Toothpaste 2.75 oz Tube Label

DawnMist®

NDC: 65517-2017-0

ORAL CARE

Gel Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

2.75 OZ. (78 g)

INGREDIENTS AND APPEARANCE

DAWNMIST FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-2017
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)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65517-2017-0	78 g in 1 TUBE; Type 0: Not a Combination Product	07/14/2017
2	NDC: 65517-2017-1	17 g in 1 TUBE; Type 0: Not a Combination Product	07/14/2017
3	NDC: 65517-2017-2	24 g in 1 TUBE; Type 0: Not a Combination Product	07/14/2017
4	NDC: 65517-2017-3	43 g in 1 TUBE; Type 0: Not a Combination Product	07/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/17/2014

Labeler - DUKAL Corporation (791014871)