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

Purpose

Antigingivitis/antiplaque

Description

ANTIPLAQUE: Cetylpyridinium chloride .05%


Medication Information

Uses

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

Purpose

Antigingivitis/antiplaque

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.
Inactive Ingredients

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

Description

ANTIPLAQUE: Cetylpyridinium chloride .05%

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

Active Ingredient

ANTIPLAQUE:

Cetylpyridinium chloride .05%


Structured Label Content

Uses

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

Purpose

Antigingivitis/antiplaque

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.
Inactive Ingredients (Inactive ingredients)

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

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)
Questions

 Call toll-free 800-323-2220

Active Ingredient (Active ingredient)

ANTIPLAQUE:

Cetylpyridinium chloride .05%


Advanced Ingredient Data


Raw Label Data

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