DAWNMIST - toothbrush, toothpaste and floss kit paste 
Donovan Industries, Inc.

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 Toothbrush, Toothpaste and Floss Kit


DRUG FACTS

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

Sorbitol, Silica, Water, Sodium Lauryl Sulfate,

Xanthan Gum, Sodium Benzoate, Titanium Dioxide,

Peppermint Oil, Sodium Saccharin

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

Manufactured for:

Donovan Industries, Inc.

Tampa, FL 33626-3061

www.dawnmist.com

1-800-334-4404

MADE IN MALAYSIA

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

Donovan Kit

Fulijaya Kit Part 1

Fulijaya Kit Part 2

DAWNMIST 
toothbrush, toothpaste and floss kit paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-0540
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 3 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55504-0540-12.83 g in 1 KIT
2NDC:55504-0540-22.83 g in 1 KIT
3NDC:55504-0540-33 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2009
Labeler - Donovan Industries, Inc. (096662267)
Registrant - Fulijaya Manufacturing SDN. BHD. (652087115)
Establishment
NameAddressID/FEIBusiness Operations
Fulijaya Manufacturing SDN. BHD.652087115manufacture
Establishment
NameAddressID/FEIBusiness Operations
Donovan Industries, Inc.096662267import

Revised: 8/2009
Document Id: 60f08b51-e2cd-4939-9acb-401fd3a718ac
Set id: 85a0fde5-4d1c-450f-9e65-2849b43a72e2
Version: 3
Effective Time: 20090818
 
Donovan Industries, Inc.