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 Item Code (Source) NDC:63783-400
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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 Item Code (Source) NDC:63783-401
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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 Item Code (Source) NDC:63783-402
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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 Item Code (Source) NDC:63783-403
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE .044 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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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