DAWNMIST - sodium fluoride paste 
Donavan

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 toothpaste

sodium fluroide 0.22 % anticavity

calcium carbonate, water, sorbitol, silica, sodium lauryl sulphate, flavor, carboxyl methyl cellulose, sodium benzoate, sodium saccharin, potassium nitrate, menthol

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.

aids in the prevention of dental cavities.

aids in the prevention of dental cavities.

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.

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.

expiration date: expiration date and batch no. on crimp of tube.

dawnmist anticavity fluoride toothpaste.carton image

DAWNMIST 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-4341
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) sodium fluoride39.9 g  in 181.4 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
PEPPERMINT (UNII: V95R5KMY2B)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
SODIUM FLUORIDE (UNII: 8ZYQ1474W7)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINT (peppermint flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55504-4341-8181.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/01/2011
Labeler - Donavan (096662267)

Revised: 1/2012
Document Id: 87b9b288-0dd8-4b02-90b2-bb09ab8838c6
Set id: 638050f5-3f08-4352-85d8-d4291d0d6237
Version: 4
Effective Time: 20120123
 
Donavan