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Dawnmist Fluoride by Dukal Corporation

Medically reviewed on September 25, 2017

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: Dukal Corporation
NDC Code: 65517-1000

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(R) Anticavity Fluoride Toothpaste

Active Ingredient

Sodium Monofluorophosphate 0.76 percent

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Keep out of reach of children

under 6 years of age

Warning

If you accidentally 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 dentist or physician.

Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Flavor, Tetrasodium Pyrophosphate, Cellulose Gum, Sodium Benzoate, Sodium Saccharin

Package Label

DawnMist (R)

Anticavity Fluoride Toothpaste

Cavity Fighting Formula

Fresh Minty Taste

Expiration Date: Expiration Date on Crimp of Tube.

Manufactured for:

DUKAL CORPORATION
Ronkonkoma, NY 11779
(631) 656-3800

Made in Malaysia


DAWNMIST FLUORIDE  
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-1000
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (MONOFLUOROPHOSPHATE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
SACCHARIN SODIUM DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:65517-1000-017 g in 1 TUBE
2NDC:65517-1000-124 g in 1 TUBE
3NDC:65517-1000-242 g in 1 TUBE
4NDC:65517-1000-378 g in 1 TUBE
5NDC:65517-1000-41 TUBE (TUBE) in 1 BOX
542 g in 1 TUBE
6NDC:65517-1000-51 TUBE (TUBE) in 1 BOX
678 g in 1 TUBE
7NDC:65517-1000-61 TUBE (TUBE) in 1 BOX
7135 g in 1 TUBE
8NDC:65517-1000-71 TUBE (TUBE) in 1 BOX
8181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/24/2012
Labeler - Dukal Corporation (791014871)

 
Dukal Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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