DAWNMIST GEL FLUORIDE- gel fluoride toothpaste gel, dentifrice 
Dukal LLC

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65517-2004 - DawnMist Gel Fuoride Toothpaste

DawnMist Gel 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.

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.

Sorbitol, Hydrated Silica, Glycerin, Water, PEG-400, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Xanthan Gum, Sodium Saccharin

DawnMist NDC: 65517-2004-1

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

GTP6454

DawnMist NDC: 65517-2004-2

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

GTP4661

DawnMist NDC: 65517-2004-3

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

GTP4678

DawnMist NDC: 65517-2004-0

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

GTP4685

DAWNMIST GEL FLUORIDE 
gel fluoride toothpaste gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2004
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
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-2004-117 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
2NDC:65517-2004-078 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
3NDC:65517-2004-224 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
4NDC:65517-2004-343 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/01/2024
Labeler - Dukal LLC (791014871)

Revised: 3/2024
Document Id: 14443184-1695-70b9-e063-6394a90a86fe
Set id: 14443184-1694-70b9-e063-6394a90a86fe
Version: 1
Effective Time: 20240322
 
Dukal LLC