QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]

QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]
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NDC 53462-306-60, 53462-308-60
Set ID d56b7b37-f818-4e7f-9443-3bf7e5a530ee
Category HUMAN OTC DRUG LABEL
Packager Sage Products LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • Drug Facts

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

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

  • 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

    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.

  • DOSAGE & ADMINISTRATION

  • 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.
  • Inactive ingredients

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

  • Questions?

    Call toll-free 800-323-2220.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    Bag Label
  • PRINCIPAL DISPLAY PANEL

    Bag Label
    Film Label
  • PRINCIPAL DISPLAY PANEL

    Burst Pouch
  • INGREDIENTS AND APPEARANCE
    QCARE 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-306
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-306-601 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 POUCH 28 mL
    Part 1 of 1
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source)NDC:53462-375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 PACKET
    17 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/28/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/28/2001
    QCARE 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-308
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-308-601 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 POUCH 21 mL
    Part 1 of 1
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source)NDC:53462-375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 PACKET
    17 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/28/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/28/2001
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Products LLC054326178MANUFACTURE(53462-308, 53462-306)

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