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Gingimed

stannous fluoride · Gingimed is a prescription drug containing stannous fluoride, made by Massco Dental.

Type
Prescription
Drug class
Not classified
Route
Oral
Manufacturers
1

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

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

STANNOUS FLUORIDE

Uses

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.

When using this product

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

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients

GLYCERIN, FLAVOR,XYLITOL

Forms and strengths

From the FDA NDC Directory · 3 product codes

Dosage formStrengthRouteNDCs
Liquid.19 g/100goral3

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 718 reports that list stannous fluoride, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Oral discomfort101
  • Drug ineffective80
  • Oral pain51
  • Toothache46
  • Stomatitis43
  • Gingival pain41
  • Oral mucosal exfoliation34
  • Lip swelling33
  • Tooth discoloration32
  • Condition aggravated30

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • Massco DentalShown hereLabel 12/17/2023 · NDC 63783-210, 63783-211, 63783-212Full label

Gingimed: common questions

What is Gingimed used for?
APPROVED USES: RELIEF OF DENTINAL HYPERSENSITIVITY. CONTROL OF PERIO INFECTION.
Is Gingimed a prescription drug?
Yes. Gingimed is a prescription (Rx) drug.
Are there other products with the same active ingredient as Gingimed?
Yes. Other FDA-listed products with the same active ingredients include Burkhart, Doctors Choice, Gelato Perio Maintenance Rinse, Kids Choice.
Who makes Gingimed?
Massco Dental lists Gingimed with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/17/2023 · Label text is shown as published by the manufacturer. Not medical advice

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