Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 7f79eb00-86df-4284-b415-47f45e4849da
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.53 mg)
Inactive Ingredients
Glycerin Methylparaben Propylparaben Saccharin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1967-07-01

Description

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

Purpose

anticavity, antigingivitis, antihypersensitivity, mouthrinse


Medication Information

Purpose

anticavity, antigingivitis, antihypersensitivity, mouthrinse

Description

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

Uses
  • aids in the prevention of childhood dental decay
  • helps prevent gingivitis
  • helps control plaque bacteria
  • builds increasing protection against painful tooth sensitivity
Section 50565-1
  • 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.
Section 50566-9
  • Stop use and ask a doctor if sensitivity persists or worsens.
  • Sensitive teeth may indicate a serious problem that may need prompt care.
Section 50567-7
  • When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
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
Active Ingredient

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

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 (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 – 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 (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)


Structured Label Content

Uses
  • aids in the prevention of childhood dental decay
  • helps prevent gingivitis
  • helps control plaque bacteria
  • builds increasing protection against painful tooth sensitivity
Section 50565-1 (50565-1)
  • 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.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if sensitivity persists or worsens.
  • Sensitive teeth may indicate a serious problem that may need prompt care.
Section 50567-7 (50567-7)
  • When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
Purpose

anticavity, antigingivitis, antihypersensitivity, mouthrinse

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
Active Ingredient (Active ingredient)

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

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-634-2249

Principal Display Panel – Box Label (mint – 78 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 – 283.5 G) (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 (tropical Fruit – 283.5 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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)