DAWNMIST- toothpaste paste, dentifrice 
Dukal LLC

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65517-2005 - DawnMist Fluoride Toothpaste

DawnMist Fluoride Toothpaste

Sodium Fluoride 0.22%

Anticavity

Aids in the prevention of dental cavities.

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.

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.

Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben

DawnMist NDC: 65517-2005-0

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

RTP06

DawnMist NDC: 65517-2005-1

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

RTP085

DawnMist NDC: 65517-2005-2

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

RTP15

DawnMist NDC: 65517-2005-3

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

RTP27

DawnMist NDC: 65517-2005-4

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

4.75 OZ. (134 g)

RTP47B

DawnMist NDC: 65517-2005-5

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

6.4 OZ. (181 g)

RTP64

DAWNMIST 
toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2005
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)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-2005-017 g in 1 TUBE; Type 0: Not a Combination Product03/25/2024
2NDC:65517-2005-124 g in 1 TUBE; Type 0: Not a Combination Product03/25/2024
3NDC:65517-2005-243 g in 1 TUBE; Type 0: Not a Combination Product03/25/2024
4NDC:65517-2005-378 g in 1 TUBE; Type 0: Not a Combination Product03/25/2024
5NDC:65517-2005-4134 g in 1 TUBE; Type 0: Not a Combination Product03/25/2024
6NDC:65517-2005-5181 g in 1 TUBE; Type 0: Not a Combination Product03/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/25/2024
Labeler - Dukal LLC (791014871)

Revised: 3/2024
Document Id: 147f7738-5081-9907-e063-6294a90a6170
Set id: 147f7738-5080-9907-e063-6294a90a6170
Version: 1
Effective Time: 20240325
 
Dukal LLC