Label: MEDICHOICE ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 25, 2011

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  • 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

    tube6oz

  • Product Outer Packaging 144ct

    box6

  • INGREDIENTS AND APPEARANCE
    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)
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