Label: QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE- cetylpyridinium chloride kit

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 23, 2019

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  • Drug Facts

    Suction Swab with Antiseptic Oral Rinse

    Active Ingredient:

    Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:

    Cetylpyridinium chloride 0.05%

    Purpose
    Antiseptic Rinse
    *Compatible for use with 0.12% Chlorhexidine Gluconate (CHG) oral rinse, tested for use up to five minutes.
    NOTE: The following Uses and Directions refer to the Suction Toothbrush and Swab. For Warnings, Uses and Directions specific to the CHG rinse including use in children under 18 years of age, refer to that product’s package insert and labeling.

  • Uses

    Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse

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

    Suction Toothbrush CHG compatible*

    • Aids in the removal of dental plaque, debris and secretions.

    Oropharyngeal Suction Catheter Non-sterile

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

    Suction Swab with Antiseptic Oral Rinse
    Before opening, turn package over, burst solution packet with thumbs.

    • Peel lid to open.
    • Remove Mouth Moisturizer and Applicator Swab.
    • 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.
    • Place Mouth Moisturizer on Applicator Swab.
    • Apply as needed to lips and inside mouth.
    • 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.


    Suction Toothbrush CHG compatible*

    • Peel lid to open.
    • Remove Suction Toothbrush and attach to suction line.
    • When using with a cleansing solution, refer to the product packaging for indications, instructions and warnings.
    • To suctions, place thumb over port.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard Suction Toothbrush. Reattach Covered Yankauer to suction line.
    • Use Swab for additional cleansing as needed.
    • Use two 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 Yankauer to suction line.
    • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
    • Oropharyngeal Suction Catheter Non-sterile

    Caution

    • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practitioner.

  • Inactive Ingredients

    Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse


    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

    NOT MADE WITH NATURAL RUBBER LATEX • FOR SINGLE USE ONLY • MADE IN U.S.A.

    Manufactured for:
    Sage Products LLC
    Cary, IL 60013

    1-800-323-2220

  • QCare Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

    6994 Bag Label

    6994 Film6994 Blister Label

  • Corinz Label

    Corinz Label

  • INGREDIENTS AND APPEARANCE
    QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-994
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-994-601 in 1 KIT; Type 1: Convenience Kit of Co-Package11/16/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKET 28 mL  in 2 
    Part 2
    Part 1 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 CHLORIDE0.5 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
    14 in 1 PACKET
    17 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/11/2016
    Part 2 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/16/2016
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Products LLC054326178manufacture(53462-994, 53462-375)