Label: ORTHO GUARD- sodium fluoride gel, dentifrice

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

Drug Label Information

Updated December 17, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT (IN EACH 10 ml)

    SODIUM FLUORIDE 4.4 mg

  • PURPOSE

    Purpose

    Anticavity

  • INACTIVE INGREDIENT

    Inactive Ingredients: Deionized water, monosodium

    phosphate, phosphoric acid, sodium benzoate, sodium

    saccharin, artificial coloring, artificial flavoring.

  • INDICATIONS & USAGE

    Use

    Aids in the prevention of dental decay

  • WARNINGS

    Warnings

    • When using this product, do not swallow unless 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.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Use As Directed

    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

  • GENERAL PRECAUTIONS

    OTHER INFORMATION

    • Store at room temperature.
  • QUESTIONS

    QUESTIONS? COMMENTS?

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

  • 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

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  • INGREDIENTS AND APPEARANCE
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63783-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE4.4 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (ICY COOL MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-400-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/1989
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63783-401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE4.4 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (GRAPE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-401-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/1989
    ORTHO GUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63783-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE4.4 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (STRAWBERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-403-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/1989
    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(63783-400, 63783-401, 63783-403)
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