MEDICHOICE PREMIUM ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice

MediChoice Premium Anticavity Fluoride by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Sodium Fluoride - 0.243% (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 older: 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

sorbitol, silica, water, glycerin, polythelene glycol 1500, sodium lauryl sulfate, flavor, titanium dioxide, cellulose gum, carrageenan, trisodium orthophosphate, sodium saccharin, sodium benzoate, tetrasodium pyrophosphate, methylparaben, propylparaben, FD & C blue #1

Package labeling

INGREDIENTS AND APPEARANCE

MEDICHOICE PREMIUM ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0603
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0603-2	24 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 (847412269)

Registrant - Owens & Minor, Inc (847412269)