Drug Facts
| Active ingredient: | Purpose |
| Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse: | |
| Cetylpyridinium chloride 0.05% | Antiseptic Rinse |
Qcare Oral Cleansing And Suctioning System
FDA Label NDC 53462-464
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sage Products Llc for the product Qcare Oral Cleansing And Suctioning System (NDC 53462-464). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, uses, warnings, otc - keep out of reach of children, directions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.
- Aids in the removal of secretions from the oropharyngeal cavity only.
Oropharyngeal Suction Catheter Non-sterile
Warnings
- 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
- 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.
- 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.
- 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
Corinz-label (Corinz Label)
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM
R4735-6462-bag (R4735 6462 Bag)
R4736-6464-bag (R4736 6464 Bag)
R5477-6462-film (R5477 6462 Film)
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