Antiplaque Solution

Antiplaque Solution
SPL v13
SPL
SPL Set ID 881d4d08-4b45-486a-93af-18c0e00a5b0e
Route
BUCCAL
Published
Effective Date 2023-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.5 mg)
Inactive Ingredients
Water Sorbitol Peppermint Potassium Sorbate Fd&c Blue No. 1 Polysorbate 80 Polysorbate 20 Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-01-09

Description

ANTIPLAQUE: Cetylpyridinium chloride .05%

Purpose

Antigingivitis/antiplaque


Medication Information

Purpose

Antigingivitis/antiplaque

Description

ANTIPLAQUE: Cetylpyridinium chloride .05%

Uses

Aids in the removal and prevention of plaque that leads to gingivitis.

Section 50565-1

Keep out of reach of children under 6 year of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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.
Section 51945-4
Questions

 Call toll-free 800-323-2220

Directions
  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Toothbrush to suction line.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, place thumb over port.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Toothbrush.  Reattach Covered Yankauer to suction line.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
  • Children ages 6 to 12 years: supervise use.
  • Children under 6 years of age: do not use.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.
Active Ingredient

ANTIPLAQUE:

Cetylpyridinium chloride .05%

Inactive Ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1


Structured Label Content

Uses

Aids in the removal and prevention of plaque that leads to gingivitis.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 year of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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.
Section 51945-4 (51945-4)
Purpose

Antigingivitis/antiplaque

Questions

 Call toll-free 800-323-2220

Directions
  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Toothbrush to suction line.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, place thumb over port.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Toothbrush.  Reattach Covered Yankauer to suction line.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
  • Children ages 6 to 12 years: supervise use.
  • Children under 6 years of age: do not use.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.
Active Ingredient (Active ingredient)

ANTIPLAQUE:

Cetylpyridinium chloride .05%

Inactive Ingredients (Inactive ingredients)

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1


Advanced Ingredient Data


Raw Label Data

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