Your browser does not support JavaScript! ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]
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ORTHO GUARD (sodium fluoride) gel, dentifrice
[Massco Dental A Division of Dunagin Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 MINT


ORTHO ORANGE


ORTHO STRAWBERRY

ORTHO GRAPE

ORTHO GUARD 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63783-400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.044 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989
ORTHO GUARD 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63783-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.044 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989
ORTHO GUARD 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63783-402
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.044 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (ORANGE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-402-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1998
ORTHO GUARD 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63783-403
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.044 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989
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

Revised: 2/2012
 
Massco Dental A Division of Dunagin Pharmaceuticals

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