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  5. Label Information: Qcare Oral Cleansing And Suctioning System Compatible With 0.12% Chlorhexidine Gluconate (chg) Oral Rinse

FDA Label for Qcare Oral Cleansing And Suctioning System Compatible With 0.12% Chlorhexidine Gluconate (chg) Oral Rinse

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USES
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS
    7. QUESTIONS?
    8. OTHER
    9. QCARE ORAL CLEANSING & SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE
    10. CORINZ LABEL

Qcare Oral Cleansing And Suctioning System Compatible With 0.12% Chlorhexidine Gluconate (chg) Oral Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Sage Products Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

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.

Otc - 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



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


Other



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


Corinz Label



Corinz Label - corinz label

Corinz Label - corinz label


* Please review the disclaimer below.