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

  • NDC Code(s): 63783-011-04, 63783-012-04, 63783-013-04, 63783-016-04
  • Packager: Massco Dental A Division of Dunagin Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 13, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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

    DOCTOR CHOICE NATURAL LABEL

    DOCTOR CHOICE CARRIBEAN 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 other01/01/1989
    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 other01/01/1989
    DOCTORS CHOICE 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-013
    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
    FlavorGRAPE (CARIBBEAN ICE FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-013-04120 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 other01/01/1989
    DOCTORS CHOICE 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-016
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-016-04120 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 other01/01/1989
    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, 63783-013, 63783-016)