antiseptic oral rinse

antiseptic oral rinse
SPL v11
SPL
SPL Set ID efff8bae-154d-46bc-8dd4-716800425663
Route
buccal
Published
Effective Date 2018-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.5 mg)
Inactive Ingredients
sorbitol peppermint potassium sorbate polysorbate 80 polysorbate 20 citric acid monohydrate fd&c blue no. 1 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2000-06-21
Purpose

Antiseptic Rinse

Description

Cetylpyridinium chloride .05%

Medication Information

Purpose

Antiseptic Rinse

Directions
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab.  Instruct to expectorate.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Description

Cetylpyridinium chloride .05%

Questions?

Call toll free 800-323-2220

Use

Helps reduce chance of infection in minor oral irritation.

Section 50565-1

Keep out of reach of children.

If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if:

• Sore mouth symptoms do not improve in 7 days.

• Swelling, rash or fever develops.

• Irritation, pain or redness persists or worsens.

Active Ingredient

Cetylpyridinium chloride .05%

Antiseptic Oral Rinse

Structured Label Content

Purpose

Antiseptic Rinse

Directions
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab.  Instruct to expectorate.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

Call toll free 800-323-2220

Use

Helps reduce chance of infection in minor oral irritation.

Section 50565-1 (50565-1)

Keep out of reach of children.

If more than used for antisepsis 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:

• Sore mouth symptoms do not improve in 7 days.

• Swelling, rash or fever develops.

• Irritation, pain or redness persists or worsens.

Active Ingredient (Active ingredient)

Cetylpyridinium chloride .05%

Antiseptic Oral Rinse

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.734841 · Updated: 2026-03-14T23:11:10.262850