SPL v8
SPL
SPL Set ID e07e291b-2cdd-444a-a510-1e9199323f38
Route
ORAL
Published
Effective Date 2019-12-02
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.19 g)
Inactive Ingredients
Glycerin Xylitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 1989-01-01

Description

STANNOUS FLUORIDE


Medication Information

Description

STANNOUS FLUORIDE

Use

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

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

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Active Ingredient

STANNOUS FLUORIDE

Other Information

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

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

Inactive Ingredients

GLYCERIN, FLAVOR,XYLITOL

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Use (USE)

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

Warnings (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 (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

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Active Ingredient (ACTIVE INGREDIENT)

STANNOUS FLUORIDE

Other Information (OTHER INFORMATION)

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

Directions for Use (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

Inactive Ingredients (INACTIVE INGREDIENTS)

GLYCERIN, FLAVOR,XYLITOL

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

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