Periomed Rinse
FDA Label NDC 48878-3315

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Solventum Us Llc for the product Periomed (NDC 48878-3315). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

Otc - Keep Out Of Reach Of Children

  • 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)

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)

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)

* Please review the disclaimer below.