MEDICHOICE FLUORIDE- sodium monofluorophosphate paste, dentifrice

MediChoice Fluoride by

Drug Labeling and Warnings

MediChoice Fluoride by is a Otc medication manufactured, distributed, or labeled by Owens & Minor Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Sodium Monoflurophosphate - 0.76% (0.15% w/v fluoride ion)

PURPOSE

Anticavity

USE

Aids in the prevention of dental cavities

WARNINGS

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Adults and children 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or a doctor.

INACTIVE INGREDIENTS

CALCIUM CARBONATE,WATER,SORBITOL,PRECIPITATED SILICA,SODIUM LAURYL SULFATE, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE TETRA SODIUM PYROPHOSPHATE, SODIUM SACCHARIN,METHYLPARABEN,TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400,PROPYLPARABEN

Pacakge Labeling:

INGREDIENTS AND APPEARANCE

MEDICHOICE FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0602
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0602-1	17 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/01/2013

Labeler - Owens & Minor Inc. (847412269)

Registrant - Owens & Minor Inc. (847412269)