Label: QCARE- cetylpyridinium chloride

  • NDC Code(s): 53462-306-60, 53462-308-60
  • Packager: Sage Products LLC
  • 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 03/15

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

  • Drug Facts

    Active ingredient: Purpose
    CORINZ ANTISEPTIC CLEANSING AND MOISTURIZING ORAL RINSE:
    Cetylpyridinium chloride 0.05% Antiseptic Rinse
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  • Uses

    • 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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  • 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.

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  • Directions

    Toothette Oral Care Suction Toothbrush

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • 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.
    • 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.

    Toothette Oral Care Suction Swab

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • Attach Suction Swab 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 Suction Swab. Reattach Covered Yankauer to suction line.
    • 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 ingredients

    Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose, citric acid, sodium saccharin, menthol.

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  • Questions?

    Call toll-free 800-323-2220.

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  • SPL UNCLASSIFIED SECTION

    LATEX FREE • FOR SINGLE USE ONLY • MADE IN U.S.A.

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  • INGREDIENTS AND APPEARANCE
    QCARE 
    cetylpyridinium chloride kit
    Product Information
    Product Type HUMAN OTC DRUG 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; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 4 POUCH 28 mL
    Part 1 of 1
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source) NDC:53462-375
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 PACKET
    1 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
    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 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; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 POUCH 21 mL
    Part 1 of 1
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source) NDC:53462-375
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 PACKET
    1 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
    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 LLC (054326178)
    Registrant - Sage Products LLC (054326178)
    Establishment
    Name Address ID/FEI Business Operations
    Sage Products LLC 054326178 MANUFACTURE(53462-308, 53462-306)
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