Label: DAWNMIST- sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 23, 2012

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  • ACTIVE INGREDIENT

    sodium fluroide 0.22 % anticavity

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    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.

  • INDICATIONS & USAGE

    aids in the prevention of dental cavities.

  • PURPOSE

    aids in the prevention of dental cavities.
  • KEEP OUT OF REACH OF CHILDREN

    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.

  • WARNINGS

    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.
  • USER SAFETY WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    dawnmist anticavity fluoride toothpaste.carton image

  • INGREDIENTS AND APPEARANCE
    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)
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