Label: ANTISEPTIC ORAL RINSE- cetylpyridinium chloride mouthwash

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

Drug Label Information

Updated November 15, 2024

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  • Active ingredient

    Cetylpyridinium chloride .05%

  • Purpose

    Antiseptic Rinse

  • Use

    Helps reduce chance of infection in minor oral irritation.

  • WARNINGS

  • STOP USE

    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.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • 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

  • Antiseptic Oral Rinse

    AOR packet

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC ORAL RINSE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-175
    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:53462-175-607 mL in 1 PACKET; Type 0: Not a Combination Product12/28/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02206/21/2000
    Labeler - Sage Products LLC (054326178)
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