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

Purpose

anticavity, antigingivitis, antihypersensitivity, mouthrinse

Description

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


Medication Information

Uses
  • aids in the prevention of childhood dental decay
  • helps prevent gingivitis
  • helps control plaque bacteria
  • builds increasing protection against painful tooth sensitivity
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
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

Description

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

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.
Active Ingredient

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

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
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
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

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.
Active Ingredient (Active ingredient)

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

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

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