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Ortho Guard

Generic Name: sodium fluoride
Dosage Form: gel, dentifrice

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

ACTIVE INGREDIENT (IN EACH 10 ml) 

SODIUM FLUORIDE 4.4 mg  PURPOSE - ANTICAVITY

INACTIVE INGREDIENTS

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

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 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

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

QUESTIONS ? COMMENTS ?

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

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.

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 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
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
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
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
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 Operations
Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture
Revised: 02/2012
 
Massco Dental A Division of Dunagin Pharmaceuticals



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