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PerioMed

3M ESPE Dental Products


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 Type Human otc drug label Item Code (Source) NDC:48878-3315
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 6.3 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 283.5 in 1 BOTTLE, PLASTIC
2 85 in 1 BOTTLE, PLASTIC
3 NDC:48878-3315-2 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1967-07-01


PerioMed

stannous fluoride RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-3316
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 6.3 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 283.5 in 1 BOTTLE, PLASTIC
2 NDC:48878-3316-0 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1967-07-01


PerioMed

stannous fluoride RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-3317
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 6.3 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 283.5 in 1 BOTTLE, PLASTIC
2 NDC:48878-3317-0 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1967-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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