Label: ANTIPLAQUE SOLUTION- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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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 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 DrugM02201/09/2009
    Labeler - Sage Products LLC (054326178)
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