PERIOMED- stannous fluoride rinse

PerioMed by

Drug Labeling and Warnings

PerioMed by is a Otc medication manufactured, distributed, or labeled by 3M ESPE Dental Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

PERIOMED 
stannous fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48878-3315
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
stannous fluoride (UNII: 3FTR44B32Q) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
saccharin (UNII: FST467XS7D)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48878-3315-0	1 in 1 BOX	07/01/1967
1		283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 48878-3315-2	1 in 1 BOX	02/01/2016
2		85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/1967

PERIOMED 
stannous fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48878-3317
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
stannous fluoride (UNII: 3FTR44B32Q) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
saccharin (UNII: FST467XS7D)

Product Characteristics
Color		Score
Shape		Size
Flavor	FRUIT (FRUIT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48878-3317-0	1 in 1 BOX	07/01/1967
1		283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/1967

Labeler - 3M ESPE Dental Products (801390852)