MEDICHOICE ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice

MEDICHOICE ANTICAVITY FLUORIDE by

Drug Labeling and Warnings

MEDICHOICE ANTICAVITY FLUORIDE by is a Otc medication manufactured, distributed, or labeled by Owens and Minor. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.22% 

Purpose

Anticavity

Use:

Aids in the prevention of dental cavities.

Directions

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.

Warning

If you accidentally swallow more than used for brushing seek professional assistance or contact a Poison Control Center Immediately.

Keep out of reach of children

under 6 years of age.

Inactive Ingredients

Inactive Ingredients:

Calcium Carbonate, Water, Sorbitol, Sodium Lauryl Sulfate, Silica, Carboxymethyl Cellulose, Flavor, Potassium Nitrate, Sodium benzoate, Sodium saccharin, menthol

SPL UNCLASSIFIED SECTION

Expiration Date: Expiration Date and Batch No. on crimp of Tube

SPL UNCLASSIFIED SECTION

E.c No.: DD/COS/DD/C/52

Made in India

MediChoice                                    Reorder: 2002PC7306

Distributed by: Owens and Minor

Mechanicsville, VA 23116    804.723.7000

Product Tube Label

Product Outer Packaging 144ct

INGREDIENTS AND APPEARANCE

MEDICHOICE ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0601
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	22 g  in 100 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)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0601-1	5 in 1 CASE
1		144 in 1 BOX
1		17 g in 1 TUBE
2	NDC: 39892-0601-2	5 in 1 CASE
2		144 in 1 BOX
2		24 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/18/2010

Labeler - Owens and Minor (847412269)