Label: ORTHO GUARD - sodium fluoride gel, dentifrice

  • NDC Code(s): 63783-400-16, 63783-401-16, 63783-402-16, 63783-403-16
  • Packager: Massco Dental A Division of Dunagin Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

Drug Label Information

Updated 02/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT (IN EACH 10 ml) 

    SODIUM FLUORIDE 4.4 mg  PURPOSE - ANTICAVITY

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  • INACTIVE INGREDIENTS

    INACTIVE INGREDIENTS: DEMINERALIZED WATER, MONOSODIUM PHOSPHATE, SODIUM BENZOATE, SODIUM SACCHARIN, ARTIFICIAL COLORING, ARTIFICIAL FLAVORING

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  • USE

    AIDS IN THE PREVENTION OF DENTAL DECAY

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • DIRECTIONS FOR USE

    ADULTS AND CHILDREN 6 YEARS AND OLDER

    USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING.

    CHILDREN UNDER 6

    CONSULT A DENTIST OR PHYSICIAN

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  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

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  • QUESTIONS ? COMMENTS ?

    QUESTIONS? COMMENTS?  CALL 1-479-787-5168 M-F 9 am TO 5pm CST

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  • WARNINGS

    WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

    IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR RINSING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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  • PACKAGE LABEL

    ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE 0.044% SODIUM FLUORIDE IN AN ACIDULATED PHOSPHATE TOPICAL SOLUTION.  MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE AR (479) 787-5168.  WWW.MASSCODENTAL.NET


    ORTHO MINT


    ORTHO ORANGE


    ORTHO STRAWBERRY

    ORTHO GRAPE

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  • INGREDIENTS AND APPEARANCE
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63783-400
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    SODIUM BENZOATE  
    SACCHARIN SODIUM  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (ICY COOL MINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63783-400-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/01/1989
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63783-401
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    SODIUM BENZOATE  
    SACCHARIN SODIUM  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (GRAPE) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63783-401-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/01/1989
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63783-402
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    SODIUM BENZOATE  
    SACCHARIN SODIUM  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor ORANGE (ORANGE) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63783-402-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/01/1998
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63783-403
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    SODIUM BENZOATE  
    SACCHARIN SODIUM  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor STRAWBERRY (STRAWBERRY) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63783-403-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/01/1989
    Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Establishment
    Name Address ID/FEI Business Operations
    Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture
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