FDA Label for Qcare Oral Cleansing And Suctioning System

View Indications, Usage & Precautions

Qcare Oral Cleansing And Suctioning System 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



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.
  • 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



    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.

Package Label.Principal Display Panel



Corinz Label

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM


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