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ACTIVE INGREDIENT
STANNOUS FLUORIDE
INACTIVE INGREDIENTS
GLYCERIN, FLAVOR,XYLITOL
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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 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)
STANNOUS FLUORIDE
.71034 g in 120 g
Inactive Ingredients
Ingredient Name
Strength
GLYCERIN
XYLITOL
Product Characteristics
Color
Score
Shape
Size
Flavor
SPEARMINT (MINT)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
1
NDC:63783-210-06
120 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
part355
01/01/1989
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)
STANNOUS FLUORIDE
.71034 g in 120 g
Inactive Ingredients
Ingredient Name
Strength
GLYCERIN
XYLITOL
Product Characteristics
Color
Score
Shape
Size
Flavor
GRAPE (CARIBBEAN ICE)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
1
NDC:63783-211-06
120 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
part355
01/01/1989
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)
STANNOUS FLUORIDE
.71034 g in 120 g
Inactive Ingredients
Ingredient Name
Strength
GLYCERIN
XYLITOL
Product Characteristics
Color
Score
Shape
Size
Flavor
CINNAMON (CINNAMON)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
1
NDC:63783-212-06
120 g in 1 BOTTLE, WITH APPLICATOR
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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