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(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

tube label

box label

DAWNMIST FLUORIDE
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65517-1000
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI)	SODIUM MONOFLUOROPHOSPHATE	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65517-1000-0	17 g in 1 TUBE; Type 0: Not a Combination Product	09/24/2012	02/17/2015
2	NDC:65517-1000-1	24 g in 1 TUBE; Type 0: Not a Combination Product	09/24/2012	02/17/2015
3	NDC:65517-1000-2	42 g in 1 TUBE; Type 0: Not a Combination Product	09/24/2012	02/17/2015
4	NDC:65517-1000-3	78 g in 1 TUBE; Type 0: Not a Combination Product	09/24/2012	02/17/2015
5	NDC:65517-1000-4	1 in 1 BOX	09/24/2012	02/17/2015
5		42 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:65517-1000-5	1 in 1 BOX	09/24/2012	02/17/2015
6		78 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:65517-1000-6	1 in 1 BOX	09/24/2012	02/17/2015
7		135 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:65517-1000-7	1 in 1 BOX	09/24/2012	02/17/2015
8		181 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/24/2012	02/17/2015

Labeler - Dukal Corporation (791014871)

Revised: 10/2018

Document Id: 77f39f5c-6d3a-2cb7-e053-2a91aa0a322a

Set id: 29968bd9-23e4-489d-bfce-54a7ffa3c447

Version: 3

Effective Time: 20181011

Dukal Corporation