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DAWNMIST FLUORIDE by DUKAL Corporation

Medically reviewed on January 17, 2018

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.22g in 100g
Labeler: DUKAL Corporation
NDC Code: 65517-2017

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Label Image

DawnMist Gel Fluoride Toothpaste 78g (65517-2017-0)

DawnMist Gel Fluoride Toothpaste 17g (65517-2017-1)

DawnMist Gel Fluoride Toothpaste 24g (65517-2017-2)

DawnMist Gel Fluoride Toothpaste 43g (65517-2017-3)

Manufactured for:

DUKAL CORPORATION

Ronkonkoma, NY 11779

(631) 656-3800

Made in India

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DAWNMIST FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2017
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
POLYETHYLENE GLYCOL 1500 
CARBOXYMETHYLCELLULOSE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:65517-2017-078 g in 1 TUBE
2NDC:65517-2017-117 g in 1 TUBE
3NDC:65517-2017-224 g in 1 TUBE
4NDC:65517-2017-343 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/17/2014
Labeler - DUKAL Corporation (791014871)

 
DUKAL Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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