PerioMed

Dosage form: rinse
Ingredients: stannous fluoride 6.3mg 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% concentrate (0.12% w/v fluoride 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 dentist 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 once daily after brushing your teeth with a toothpaste or as directed by your dentist
  • remove cap and replace with pump
  • rotate spout counter clockwise to extend
  • depress pump until medicine comes to the tip of the pump
  • make 2 complete pump depressions into cup provided (1/8 oz)
  • add tap water to line (1 oz) on cup
  • mix using bristle end of toothbrush
  • 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 under 12 years of age 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
  • 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
  • For Professional Office Use Only
  • This product is not intended for home or unsupervised consumer use.

Inactive ingredients

glycerin, flavor

Questions or comments?

1-800-634-2249

Principal Display Panel – Box Label

Mint

NDC 48878-3315-0

3M ESPE

PerioMed™

0.63% Stannous

Fluoride Concentrate

Antimicrobial

Oral Rinse

Alcohol Free

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 10 oz (283.5g)

Principal Display Panel – Box Label

Cinnamon

NDC 48878-3316-0

3M ESPE

PerioMed™

0.63% Stannous

Fluoride Concentrate

Antimicrobial

Oral Rinse

Alcohol Free

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 10 oz (283.5g)

Principal Display Panel – Box Label

Tropical Fruit

NDC 48878-3317-0

3M ESPE

PerioMed™

0.63% Stannous

Fluoride Concentrate

Antimicrobial

Oral Rinse

Alcohol Free

IMPORTANT: Read

directions thoroughly.

OMNI

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) stannous fluoride6.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-3315-01 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1283.5 g in 1 BOTTLE, PLASTIC
2NDC:48878-3315-21 BOTTLE, PLASTIC (1 BOTTLE) 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:48878-3316
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) stannous fluoride6.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
Product Characteristics
Color    Score    
ShapeSize
FlavorCINNAMON (CINNAMON) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-3316-01 BOTTLE, PLASTIC (1 BOTTLE) 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
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) stannous fluoride6.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (FRUIT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-3317-01 BOTTLE, PLASTIC (1 BOTTLE) 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 (799975909)
Establishment
NameAddressID/FEIOperations
3M ESPE Dental Products799975909MANUFACTURE

Revised: 02/2009
 
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
(web1)