Gingimed

Dosage Form: oral liquid

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  stannous fluoride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-210-06 120 g In 1 BOTTLE, WITH APPLICATOR None

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-211-06 120 g In 1 BOTTLE, WITH APPLICATOR None

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63783-212-06 120 g In 1 BOTTLE, WITH APPLICATOR 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

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