DAWNMIST- toothbrush, toothpaste and floss kit paste

DawnMist by

Drug Labeling and Warnings

DawnMist by is a Otc medication manufactured, distributed, or labeled by Donovan Industries, Inc., Fulijaya Manufacturing SDN. BHD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredient:                                                   Purpose:
SMFP 0.76% ......................................................... Anticavity

PURPOSE

Use: Aids in the prevention of dental cavities

WARNINGS

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.

INACTIVE INGREDIENT

Directions : Adults and children 2 yrs. 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 yrs.: 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.

DESCRIPTION

Sorbitol, Silica, Water, Sodium Lauryl Sulfate,

Xanthan Gum, Sodium Benzoate, Titanium Dioxide,

Peppermint Oil, Sodium Saccharin

DESCRIPTION

Expiration Date: Expiration Date and Batch No. on Primary Package

DESCRIPTION

Manufactured for:

Donovan Industries, Inc.

Tampa, FL 33626-3061

www.dawnmist.com

1-800-334-4404

MADE IN MALAYSIA

PRINCIPAL DISPLAY PANEL

DawnMist

Cavity Fighting

Formula

Mint Flavor

Toothbrush, Toothpaste and Floss Kit

100 Kits Each Net Wt  .1 OZ 3g

CONTAINS ONE TOOTHBRUSH, ONE TUBE

OF TOOTHPASTE AND ONE FLOSS

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAWNMIST 
toothbrush, toothpaste and floss kit paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55504-0540
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	0.76 g  in 3 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEPPERMINT OIL (UNII: AV092KU4JH)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55504-0540-1	2.83 g in 1 KIT
2	NDC: 55504-0540-2	2.83 g in 1 KIT
3	NDC: 55504-0540-3	3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2009

Labeler - Donovan Industries, Inc. (096662267)

Registrant - Fulijaya Manufacturing SDN. BHD. (652087115)

Establishment
Name	Address	ID/FEI	Business Operations
Fulijaya Manufacturing SDN. BHD.		652087115	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Donovan Industries, Inc.		096662267	import