QCARE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]
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NDC 53462-462-60, 53462-464-60
Set ID 08560105-d7fc-334e-08a1-73c0f1f93b7b
Category HUMAN OTC DRUG LABEL
Packager Sage Products LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • DOSAGE FORMS & STRENGTHS

  • DOSAGE & ADMINISTRATION

  • Drug Facts

    Active ingredient: Purpose
    Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:
    Cetylpyridinium chloride 0.05%Antiseptic Rinse
  • INDICATIONS & USAGE

  • Uses

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

    Oropharyngeal Suction Catheter Non-sterile

    • Aids in the removal of secretions from the oropharyngeal cavity only.
  • 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.

  • 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.

    Oropharyngeal Suction Catheter Non-sterile

    • Peel lid to open.
    • Attach Suction Catheter to suction line.
    • Suction secretions from the oropharyngeal cavity.
    • To suction, place thumb over port.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard Suction Catheter. Reattach Covered Yankaurer to suction line.
    • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • INACTIVE INGREDIENT

    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.

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

  • PRINCIPAL DISPLAY PANEL

    Corinz Label

    corinz-label
  • PRINCIPAL DISPLAY PANEL

    QCARE ORAL CLEANSING AND SUCTIONING SYSTEM

    r4735-6462-bag
    r4736-6464-bag
    r5477-6462-film
  • INGREDIENTS AND APPEARANCE
    QCARE ORAL CLEANSING AND SUCTIONING SYSTEM 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-462
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-462-601 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug01/11/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 212 POUCH 84 mL  in 12 
    Part 1 of 2
    SODIUM BICARBONATE 
    other oral hygiene products powder
    Product Information
    Route of AdministrationBUCCAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 2 of 2
    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
    112 in 1 PACKET
    17 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/11/2016
    QCARE ORAL CLEANSING AND SUCTIONING SYSTEM 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-464
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-464-601 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug01/11/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 26 POUCH 42 mL  in 6 
    Part 1 of 2
    SODIUM BICARBONATE 
    other oral hygiene products powder
    Product Information
    Route of AdministrationBUCCAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 2 of 2
    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
    16 in 1 PACKET
    17 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/11/2016
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Products LLC054326178MANUFACTURE(53462-464, 53462-375, 53462-462)

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