Label: DOCTORS CHOICE- stanous fluoride gel, dentifrice
DOCTORS CHOICE- stannous fluoride gel, dentifrice

  • NDC Code(s): 63783-011-04, 63783-012-04
  • Packager: Massco Dental A Division of Dunagin Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Updated December 19, 2022

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  • ACTIVE INGREDIENT


    Active Ingredient: Stannous Fluoride

  • INACTIVE INGREDIENTS

    Glycerine, Hydroxy Ethyl Celluulose, Natural Flavor, Xylitol

  • USE

    Aids in the prevention of dental decay.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DIRECTIONS FOR USE

    Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.

    Children 6-11 Years:  See directions above.  Adult supervision required.

    Children Under 6: Consult a Dentist or Physician.

  • OTHER INFORMATION

    This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

  • QUESTIONS ? COMMENTS ?

    Questions?? Comments??

    Call 1-479-787-5168 M-F 9am to 5pm CST

  • WARNINGS

    If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

  • PACKAGE LABEL

    Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel

    Manufactured by Massco Dental

    DOCTOR CHOICE CINNAMON LABEL

    DOCTOR CHOICE MINT LABEL

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  • INGREDIENTS AND APPEARANCE
    DOCTORS CHOICE 
    stanous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINT (MINT FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-011-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/198912/31/2023
    DOCTORS CHOICE 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCINNAMON (CINNAMON FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-012-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/198912/31/2023
    Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Massco Dental A Division of Dunagin Pharmaceuticals008081858manufacture(63783-011, 63783-012)
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