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Name:Gingimed
Manufacturer:Massco Dental A Division Of Dunacin Pharmaceuticals
Category:Prescription Marketed Drugs


GINGIMED  - stannous fluoride liquid 
Massco Dental A Division of Dunacin Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

STANNOUS FLUORIDE

INACTIVE INGREDIENTS

GLYCERIN, FLAVOR

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.

MANUFACTURED BY MASSCO DENTAL.


CINNAMON LABEL


MINT LABEL

CARRIBEAN ICE LABEL


GINGIMED 
stannous fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:63783-210-04 120 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 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 Multilevel Packaging
1 NDC: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 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 Multilevel Packaging
1 NDC: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: 04/2011 Massco Dental A Division of Dunacin Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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