DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]

DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]
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NDC 55504-4341-8
Set ID 638050f5-3f08-4352-85d8-d4291d0d6237
Category HUMAN OTC DRUG LABEL
Packager Donavan
Generic Name
Product Class
Product Number
Application Number PART355
  • 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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