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GINGIMED

Massco Dental A Division of Dunagin Pharmaceuticals
Massco Dental A Division of Dunagin Pharmaceuticals


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

STANNOUS FLUORIDE

INACTIVE INGREDIENTS

GLYCERIN, FLAVOR,XYLITOL

USE

APPROVED USES:  RELIEF OF DENTINAL HYPERSENSITIVITY.  CONTROL OF PERIO INFECTION.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

ADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE EACH DAY AFTER USUAL BRUSHING AND FLOSSING OR MORE OFTEN IF YOUR DENTIST RECOMMENDS ADDITIONAL THERAPY BASED ON THE DIAGNOSIS.  PUSH DOWN ON PUMP TWICE OR POUR THE CONCENTRATED RINSE TO THE 1/8 FL. OX. MARK ON THE MIXING VIAL.  ADD WATER TO THE 1 OZ. LINE.  CLOSE TIGHTLY WITH SNAP-ON CAP AND SHAKE WELL.  THIS PREPARES A 0.1% STANNOUS FLUORIDE RINSE.  RINSE WITH ONE HALF OF THE SOLUTION FOR ONE MINUTE, EXPECTORATE (SPIT) AND REPEAT THE PROCEDURE WITH THE REMAINING HALF OF THE MIXTURE.  DO NOT SWALLOW AND DO NOT RINSE MOUTH.  RINSE MIXING VIAL WITH WATER AFTER EACH USE.

CHILDREN 6-12 YEARS: INSTRUCT AND SUPERVISE IN GOOD RINSING HABITS. (HELP TO MINIMIZE SWALLOWING)

CHILDREN UNDER 6: CONSULT A DENTIST.

FOR HOME IRRIGATION: PREPARE 1 OZ. OF GINGIMED RINSE AS DESCRIBED ABOVE.  POUR INTO IRRIGATOR RESIVOIR AND ADD 4 OZ. OF WATER.  MIX THOROUGHLY.  USE IRRIGATOR AS DESCRIBED

OTHER INFORMATION

THIS PRODUCT MAY CAUSE MINIMAL SURFACE DISCOLORATION ON THE TEETH, MAY BE PREVENTED BY ADEQUATE BRUSHING.

WARNINGS

IF MORE THAN AMOUNT DIRECTED FOR RINSING IS ACCIDENTALLY SWALLOWED, SEEK MEDICAL HELP FROM A POISON CONTROL CENTER.  DO NOT USE BEFORE MIXING WITH WATER.  USE AS DIRECTED BY A DENTAL PROFESSIONAL.  THIS IS A FLUORIDE TREATMENT RINSE, NOT A MOUTHWASH.

PACKAGE LABEL

ALCOHOL FREE PERIO TREATMENT.  GINGIMED  0.63% STANNOUS FLUORIDE  READ DIRECTIONS THOROUGHLY.  MIX WITH WATER BEFORE USE. NOW CONTAINING XYLITOL

MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, AR (479) 787-5168  WWW.MASSCODENTAL.NET

GINGIMED

GINGIMED

GINGIMED

GINGIMED

STANNOUS FLUORIDE LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:63783-210
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion .71034 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
Xylitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63783-210-06 120 in 1 BOTTLE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1989-01-01


GINGIMED

STANNOUS FLUORIDE LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:63783-211
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion .71034 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
Xylitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63783-211-06 120 in 1 BOTTLE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1989-01-01


GINGIMED

STANNOUS FLUORIDE LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:63783-212
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion .71034 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
Xylitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63783-212-06 120 in 1 BOTTLE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1989-01-01


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