PERIOMED- stannous fluoride rinse 
Solventum US OpCo LLC

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Drug Facts

Active ingredient

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

Purpose

anticavity, antigingivitis, antihypersensitivity, mouthrinse

Uses

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, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years of age and older:

children under 6 years of age:

Other information

Inactive ingredients

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

Questions or comments?

1-800-634-2249

Principal Display Panel – Box Label (Mint – 283.5 g)

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 (Mint – 283.5 g)

Principal Display Panel – Box Label (Mint – 78 g)

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 (Mint – 78 g)

Principal Display Panel – Box Label (Tropical Fruit – 283.5 g)

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)

Principal Display Panel – Box Label (Tropical Fruit – 283.5 g)
PERIOMED 
stannous fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3315
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Saccharin (UNII: FST467XS7D)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-3315-01 in 1 BOX07/01/1967
1283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:48878-3315-21 in 1 BOX02/01/2016
285 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/1967
PERIOMED 
stannous fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3317
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Saccharin (UNII: FST467XS7D)  
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (FRUIT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-3317-01 in 1 BOX07/01/1967
1283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/1967
Labeler - Solventum US OpCo LLC (801390852)

Revised: 4/2024
Document Id: 4a8e8597-e38a-4e51-a4fe-e7fb9c2c571e
Set id: 7f79eb00-86df-4284-b415-47f45e4849da
Version: 8
Effective Time: 20240401
 
Solventum US OpCo LLC