Skip to Content

PerioMed

Dosage form: rinse
Ingredients: stannous fluoride 1.53mg in 1g
Labeler: 3M ESPE Dental Products
NDC Code: 48878-3315

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.

Drug Facts

Active ingredient

Stannous fluoride 0.63% w/w (0.19% w/v flouride ion)

Purpose

anticavity, antigingivitis, antihypersensitivity, mouthrinse

Uses
  • aids in the prevention of childhood dental decay
  • helps prevent gingivitis
  • helps control plaque bacteria
  • builds increasing protection against painful tooth sensitivity

Warnings
  • When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
  • Stop use and ask a doctor if sensitivity persists or worsens.
  • Sensitive teeth may indicate a serious problem that may need prompt care.

  • Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions

adults and children 6 years of age and older:

  • do not use before mixing with water
  • use immediately after preparing the rinse
  • use as directed by a dental professional
  • use once a day after brushing your teeth with a toothpaste or as directed by your dentist
  • remove cap and seal and replace with pump
  • rotate spout counter clockwise to extend
  • depress pump until medicine comes to the tip of the pump
  • put 1/8 oz. (approx. 2 pump strokes) of concentrated PerioMed Rinse into the provided mixing vial
  • add water to 1 oz. line on mixing vial
  • tightly snap on the cap and shake well
  • vigorously swish rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

children under 6 years of age:

  • consult a dentist or doctor

Other information
  • For professional use only
  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing may prevent these stains which are not harmful and may be removed by your dentist
  • see your dentist regularly
  • this product is not intended for home or unsupervised consumer use
  • for your protection, do not use if seal under the cap is broken or missing

Inactive ingredients

flavor, glycerin, methyl paraben, propyl paraben, sodium saccharin

Questions or comments?

1-800-634-2249

Principal Display Panel – Box Label

NDC 48878-3315-0

Mint

3M ESPE

PerioMed™

0.63% Stannous

Fluoride Concentrate

Antimicrobial

Oral Rinse

Non-Alcohol

Formula

IMPORTANT: Read

directions carefully

before using.

Contents:

1 Bottle

NET WT. 10 oz (283.5g)

Principal Display Panel – Box Label

NDC 48878-3315-2

Mint

3M ESPE

PerioMed™

0.63% Stannous

Fluoride Concentrate

Antimicrobial

Oral Rinse

Non-Alcohol

Formula

IMPORTANT: Read

directions carefully

before using.

Contents:

1 Bottle

NET WT. 2.75 oz (78g)

Principal Display Panel – Box Label

NDC 48878-3317-0

Tropical Fruit

3M ESPE

PerioMed™

0.63% Stannous

Fluoride Concentrate

Antimicrobial

Oral Rinse

Non-Alcohol

Formula

IMPORTANT: Read

directions carefully

before using.

Contents:

1 Bottle

NET WT. 10 oz (283.5g)

PERIOMED 
stannous fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3315
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) fluoride ion1.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
methylparaben 
propylparaben 
saccharin 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-3315-01 BOTTLE, PLASTIC in 1 BOX
1283.5 g in 1 BOTTLE, PLASTIC
2NDC:48878-3315-21 BOTTLE, PLASTIC in 1 BOX
285 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/01/1967
PERIOMED 
stannous fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3317
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) fluoride ion1.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
methylparaben 
propylparaben 
saccharin 
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (FRUIT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-3317-01 BOTTLE, PLASTIC in 1 BOX
1283.5 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/01/1967
Labeler - 3M ESPE Dental Products (801390852)

Revised: 06/2016
 
3M ESPE Dental Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide