Label: QCARE- cetylpyridinium chloride   

  • NDC Code(s): 53462-175-60, 53462-306-60, 53462-308-60
  • 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 08/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Cetylpyridinium chloride .05%

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  • PURPOSE

    Antiseptic rinse

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  • 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.

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  • INDICATIONS & USAGE

    Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.

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  • 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.
    • Children under 12 years of age:  supervise use
    • Children under 3 years of age:  consult a dentist or doctor.
    • 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.
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  • INACTIVE INGREDIENT

    water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090).


    Sodium Bicarbonate ingredients:  Water, sodium bicarbonate, sodium carboxymethyl cellulose, sodium lauryl sulfate, flavor, sodium sacharin, sodium benzoate.


    Mouth Moisturizer ingredients:  Water, coconut oil, xylitol, spearmint flavor, sodium carboxymethyl cellulose, tocopheryl acetate (vitamin E), spearmint oil, carbomer, polysorbate 20, polysorbate 80, potassium sorbate, cetylpyridinium chloride.

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  • INGREDIENTS AND APPEARANCE
    QCARE 
    cetylpyridinium chloride kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53462-308
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53462-308-60 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKET 21 mL
    Part 1 of 1
    QCARE 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source) NDC:53462-175
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    cetylpyridinium chloride (cetylpyridinium) cetylpyridinium chloride 0.5 ug  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 1 in 1 POUCH
    1 NDC:53462-175-60 7 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 12/28/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 12/28/2001
    QCARE 
    cetylpyridinium chloride kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53462-306
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53462-306-60 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 4 PACKET 28 mL
    Part 1 of 1
    QCARE 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source) NDC:53462-175
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    cetylpyridinium chloride (cetylpyridinium) cetylpyridinium chloride 0.5 ug  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 1 in 1 POUCH
    1 NDC:53462-175-60 7 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 12/28/2001
    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(53462-308, 53462-306)
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