Active Ingredient
STANNOUS FLUORIDE
Gingimed Liquid
FDA Label NDC 63783-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Massco Dental for the product Gingimed (NDC 63783-210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, use, keep out of reach of children, directions for use, other information, warnings, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Cinnamon Label (Cinnamon2)
Mint Label (Mint2)
Carribean Ice Label (Caribbean2)
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