Label: DAWNMIST- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 55504-4341-8 - Packager: Donavan
- Category: HUMAN OTC DRUG LABEL
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
- INACTIVE INGREDIENT
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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
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- USER SAFETY WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAWNMIST
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55504-4341 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) sodium fluoride 39.9 g in 181.4 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor PEPPERMINT (peppermint flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55504-4341-8 181.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/01/2011 Labeler - Donavan (096662267)