Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2d867d6c-d9f9-4ee4-8221-34b1ad870fd8
Route
ORAL
Published
Effective Date 2018-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.7 mg)
Inactive Ingredients
Water Glycerin Poloxamer 407 Saccharin Sodium Methylparaben Sucralose Propylparaben Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-06-07
Description

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis/Antiplaque

Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium Chloride 0.07%

Uses
  • helps reduce plaque that lead to:
  • gingivitis
  • bleeding gums
Warnings

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Directions
  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • Children 6 years to under 12 years of age: supervise use.
  • Children under 6 years of age: do not use.
Label Copy

Active Ingredient

Cetylpyridinium Chloride 0.07%

Other Information
  • this rinse is not intended to replace brushing or flossing.
  • store at room temperature.
Inactive Ingredients

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

Questions Ro Comments?

1-866-695-3030

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidentally swalowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses
  • helps reduce plaque that lead to:
  • gingivitis
  • bleeding gums
Purpose

Antigingivitis/Antiplaque

Warnings

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Directions
  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • Children 6 years to under 12 years of age: supervise use.
  • Children under 6 years of age: do not use.
Label Copy

Active Ingredient (Active ingredient)

Cetylpyridinium Chloride 0.07%

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing.
  • store at room temperature.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

Questions Ro Comments? (Questions ro comments?)

1-866-695-3030

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidentally swalowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.880818 · Updated: 2026-03-14T22:55:08.159087