Label: ANTISEPTIC ORAL RINSE- 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

    Cetylpyridinium chloride .05%

  • Purpose

    Antiseptic Rinse

  • Use

    Helps reduce chance of infection in minor oral irritation.

  • Warnings

    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. 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 not finalpart35606/21/2000
    Labeler - Sage Products LLC (054326178)
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