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 Fluoride Toothpaste

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warning:

Keep out of reach of children under 6 years of age.

If you accidentally swallow more than used for brushing seek professional assistance or contact a Poison Control Center 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 pea sized amount and supervise brushing until good habits are established.

Children under 2 years: Ask a dentist or physician.

Inactive Ingredients

Sorbitol, Silica, Water, Sodium Lauryl Sulfate, Xanthan Gum, Sodium Benzoate, Titanium Dioxide, Mentha Piperita (Peppermint Oil), Sodium Saccharin

DawnMist Fluoride Toothpaste 0.6oz/17g (

65517-2018-0)

DawnMist™ NDC: 65517-2018-0

ORAL CARE

Gel Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

0.6 OZ. (17g)

INGREDIENTS AND APPEARANCE

DAWNMIST FLUORIDE 
sodium fluoride paste

Product 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 final	part355	01/30/2014

Labeler - Dukal Corporation (791014871)