MEDICHOICE ANTICAVITY FLUORIDE - sodium fluoride paste, dentifrice 
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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MEDICHOICE ANTICAVITY FLUORIDE TOOTHPASTE

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

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

Product Tube Label

tube6oz

Product Outer Packaging 144ct

box6

MEDICHOICE ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0601
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39892-0601-15 in 1 CASE
1144 in 1 BOX
117 g in 1 TUBE
2NDC:39892-0601-25 in 1 CASE
2144 in 1 BOX
224 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/18/2010
Labeler - Owens and Minor (847412269)

Revised: 10/2011
Document Id: 931fe295-4949-43af-8c8d-f5a9d0239222
Set id: 306f908b-8cc3-4a79-9334-d8e9c4a86e11
Version: 1
Effective Time: 20111025
 
Owens and Minor