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Gingimed Prescribing Information

Package insert / product label
Generic name: stannous fluoride
Dosage form: oral liquid
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Jul 17, 2022.

ACTIVE INGREDIENT

STANNOUS FLUORIDE

INACTIVE INGREDIENTS

GLYCERIN, FLAVOR,XYLITOL

Indications and Usage for Gingimed

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

CINNAMON LABEL
MINT LABEL
CARRIBEAN ICE LABEL

res

GINGIMED
stannous fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.19 g in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Color Score
ShapeSize
FlavorSPEARMINT (MINT) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-210-06120 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
GINGIMED
stannous fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.19 g in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Color Score
ShapeSize
FlavorGRAPE (CARIBBEAN ICE) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-211-06120 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
GINGIMED
stannous fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.19 g in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Color Score
ShapeSize
FlavorCINNAMON (CINNAMON) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-212-06120 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
Labeler - Massco Dental (008081858)
Registrant - Massco Dental (008081858)
Establishment
NameAddressID/FEIBusiness Operations
Massco Dental008081858manufacture(63783-210, 63783-211, 63783-212)