DAWNMIST FLUORIDE- sodium fluoride paste 
Dukal LLC

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DawnMist Gel Fluoride Toothpaste

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)

Principal Display Panel - DawnMist Gel Fluoride Toothpaste 2.75 oz Tube Label
DAWNMIST FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2017
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-2017-078 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
2NDC:65517-2017-117 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
3NDC:65517-2017-224 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
4NDC:65517-2017-343 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/17/2014
Labeler - Dukal LLC (791014871)

Revised: 10/2023
Document Id: 07a0a500-d4a9-db78-e063-6394a90a401c
Set id: 3cd621bd-15aa-4c81-8734-91ccc929b4d6
Version: 4
Effective Time: 20231013
 
Dukal LLC