SODIUM FLUORIDE- toothpaste cream 
DUKAL LLC

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DAWNMIST TOOTHPASTE

Active ingredient

Sodium fluoride 0.22%

Purpose

Anticavity 

Use

aids in the prevention of dental cavities  

Warnings Section

Warnings

Keep out of reach of children

Keep out of reach of children under six years of age. If you accidently 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 doctor or physician.

Inactive ingredients

calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

Expiration date

Expiration date & batch No. on crimp of tube

Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label

DawnMist®

NDC: 65517-2000-0

ORAL CARE

Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

0.6 OZ. (17 g)

Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label
SODIUM FLUORIDE 
toothpaste cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2000
Route of AdministrationORAL
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
Colorwhite (White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-2000-017 g in 1 TUBE; Type 0: Not a Combination Product02/19/201507/31/2026
2NDC:65517-2000-124 g in 1 TUBE; Type 0: Not a Combination Product02/19/201507/31/2026
3NDC:65517-2000-242 g in 1 TUBE; Type 0: Not a Combination Product02/19/201507/31/2026
4NDC:65517-2000-378 g in 1 TUBE; Type 0: Not a Combination Product02/19/201507/31/2026
5NDC:65517-2000-41 in 1 BOX02/19/201507/31/2026
542 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:65517-2000-51 in 1 BOX02/19/201507/14/2026
678 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:65517-2000-61 in 1 BOX02/19/201505/19/2026
7135 g in 1 TUBE; Type 0: Not a Combination Product
8NDC:65517-2000-71 in 1 BOX02/19/201507/31/2026
8181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02211/13/201307/31/2026
Labeler - DUKAL LLC (791014871)

Revised: 7/2024
Document Id: 1cbd9395-3d74-b411-e063-6394a90afb29
Set id: 460c0f54-367a-4300-b066-5071d718ea73
Version: 6
Effective Time: 20240708
 
DUKAL LLC