Label: CETYLPYRIDINIUM CHLORIDE - cetylpyridinium chloride mouthwash

  • NDC Code(s): 53462-175-30, 53462-175-60
  • Packager: Sage Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/12

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  • ACTIVE INGREDIENT

    Cetylpyridinium chloride .05%

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  • PURPOSE

    Antiseptic rinse

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for rinsing or swabbing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Helps reduce chance of infection in minor oral irritation.

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  • WARNINGS

    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.
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  • DOSAGE & ADMINISTRATION

    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 approximately one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette(R) oral swab.  Instruct to expectorate.
    • Children under 12 years of age: supervise use.
    • Children under 3 years of age: consult a dentist or doctor.
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  • INACTIVE INGREDIENT

    water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD and C Blue 1

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  • INGREDIENTS AND APPEARANCE
    CETYLPYRIDINIUM CHLORIDE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53462-175
    Route of Administration BUCCAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    cetylpyridinium chloride (cetylpyridinium) cetylpyridinium chloride 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    sorbitol  
    peppermint  
    potassium sorbate  
    polysorbate 80  
    polysorbate 20  
    citric acid monohydrate  
    FD&C Blue No. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53462-175-30 44 mL in 1 BOTTLE, PLASTIC
    2 NDC:53462-175-60 7 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 12/28/2001
    Labeler - Sage Products Inc. (054326178)
    Establishment
    Name Address ID/FEI Business Operations
    Sage Products Inc. 054326178 manufacture
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