DAWNMIST FLUORIDE- sodium monofluorophosphate paste
Dukal Corporation

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65517-1017
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PEPPERMINT OIL (UNII: AV092KU4JH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65517-1017-0	78 g in 1 TUBE; Type 0: Not a Combination Product	06/06/2013	01/17/2014
2	NDC:65517-1017-1	17 g in 1 TUBE; Type 0: Not a Combination Product	06/06/2013	01/17/2014
3	NDC:65517-1017-2	24 g in 1 TUBE; Type 0: Not a Combination Product	06/06/2013	01/17/2014
4	NDC:65517-1017-3	43 g in 1 TUBE; Type 0: Not a Combination Product	06/06/2013	01/17/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/06/2013	01/17/2014

Labeler - Dukal Corporation (791014871)

Revised: 9/2018

Document Id: 75b2e380-460c-96f5-e053-2991aa0ae9cc

Set id: e9e57210-ed58-41df-a6a9-a9e7a641f326

Version: 3

Effective Time: 20180912

Dukal Corporation