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DawnMist Fluoride by Dukal Corporation

Medically reviewed on June 6, 2018

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: Dukal Corporation
NDC Code: 65517-1017

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 Monofluorophosphate 0.76%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warning:

Keep out of reach of children under 6 years of age.

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

Sorbitol, Silica, Water, Cocamidopropyl Betaine, Xanthan Gum, Sodium Benzoate, Mentha Piperita (Peppermint Oil), Sodium Saccharin

DawnMist Gel Fluoride Toothpaste 2.75/78g (65517-1017-0)
DawnMist Gel Fluoride Toothpaste 0.6oz/17g (65517-1017-1)
DawnMist Gel Fluoride Toothpaste 0.85oz/24g (65517-1017-2)
DawnMist Gel Fluoride Toothpaste 1.5oz/43g (65517-1017-3)

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:65517-1017
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
COCAMIDOPROPYL BETAINE 
XANTHAN GUM 
SODIUM BENZOATE 
PEPPERMINT OIL 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:65517-1017-078 g in 1 TUBE
2NDC:65517-1017-117 g in 1 TUBE
3NDC:65517-1017-224 g in 1 TUBE
4NDC:65517-1017-343 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/06/2013
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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