Ortho Guard

Dosage Form: gel, dentifrice

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-400-16 473 mL In 1 BOTTLE None

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-401-16 473 mL In 1 BOTTLE None

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-402-16 473 mL In 1 BOTTLE None

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-403-16 473 mL In 1 BOTTLE None

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 Dunacin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Establishment
Name	Address	ID/FEI	Operations
Massco Dental A Division of Dunacin Pharmaceuticals		008081858	manufacture

Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals