Label: ANTIPLAQUE SOLUTION- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 22, 2022

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  • Active ingredient

    ANTIPLAQUE:
    Cetylpyridinium chloride .05%

  • Purpose

    Antigingivitis/antiplaque

  • Uses

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

  • 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.

    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.

  • 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

  • Questions

     Call toll-free 800-323-2220

  • PRINCIPAL DISPLAY PANEL

    Antiplaque Drug Facts
    Antiplaque Solution Packet
  • INGREDIENTS AND APPEARANCE
    ANTIPLAQUE SOLUTION 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-275
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-275-607 mL in 1 PACKET; Type 0: Not a Combination Product01/09/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/09/2009
    Labeler - Sage Products LLC (054326178)
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