MEDICHOICE ANTICAVITY FLUORIDE TOOTHPASTE

MEDICHOICE ANTICAVITY FLUORIDE - sodium fluoride paste
Owens and Minor

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.

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DRUG FACTS

Active Ingredient: Purpose

Sodium Fluoride 0.22% Anticavity

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.

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

Keep out of reach of children

Inactive Ingredients:

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

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

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

tube6oz

MEDICHOICE

Reorder: 2002PC7306

Anticavity Fluoride

Toothpaste 0.6 oz

Contents: 144/bx

Distributed by

Owens and Minor

Mechanicsville, VA 23116

Made in India

box6

Medichoice

Reorder: 2002PC7306

Anticavity Fluoride

Toothpaste 0.6

Contents: 144/bx, 5 boxes/cs, 720 cs

Distributed by

Owens and Minor

Mechanicsville, VA 23116

Made in India

case6

MEDICHOICE ANTICAVITY FLUORIDE
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:39892-0600
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	SODIUM FLUORIDE	22 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE
WATER
SORBITOL
SODIUM LAURYL SULFATE
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE
POTASSIUM NITRATE
SODIUM BENZOATE
SACCHARIN SODIUM
MENTHOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:39892-0600-1	5 BOX ( BOX) in 1 CASE	contains a BOX
1		144 TUBE ( TUBE) in 1 BOX	This package is contained within the CASE (39892-0600-1) and contains a TUBE
1		.24 g in 1 TUBE	This package is contained within a BOX and a CASE (39892-0600-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/18/2010	10/28/2011

Labeler - Owens and Minor (847412269)

Establishment
Name	Address	ID/FEI	Operations
Chester Packaging, LLC		004237806	manufacture

Revised: 10/2011 Owens and Minor