DAWNMIST- sodium fluoride paste

Drug Labeling and Warnings

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

DAWNMIST 
sodium fluoride paste

Product 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)