FDA Label for Qcare Petite Size Oral Cleansing And Suctioning System
View Indications, Usage & Precautions
Qcare Petite Size 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: ANTISEPTIC ORAL RINSE: | Purpose |
| Cetylpyridinium chloride .05% | Antiseptic Rinse |
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 dental plaque, secretions, and debris; helps reduce the chance of infection in minor oral irritation.
- Aids in the removal of secretions from the oropharyngeal cavity only.
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
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.
- Before opening, turn package over, burst solution packet with thumbs.
- Peel lid to open.
- Remove Mouth Moisturizer and Applicator Swab.
- Attach Suction 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.
- 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.
- Peel lid to open.
- Attach Suction Catheter to suction line.
- 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.
- Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner.
Suction Toothbrush with Antiseptic Oral Rinse
Oropharyngeal Suction Catheter
CAUTION:
Inactive Ingredients
Water, sorbitol, mentha piperita (peppermint) extract, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090)
Questions?
Call toll-free 800-323-2220.
Mouth Moisturizer Ingredients*
Water, cocos nucifera (coconut) oil, xylitol, flavor, cellulose gum, tocopheryl acetate (vitamin E), mentha veridis (spearmint) leaf oil, carbomer, polysorbate 20, polysorbate 80, potassium sorbate, cetylpyridinium chloride
* Manufactured for Sage Products LLC • Cary, IL
www.sageproducts.com/patents
NOT MADE WITH NATURAL RUBBER LATEX • FOR SINGLE USE ONLY • MADE IN USA
Qcare Petite Size Oral Cleansing And Suctioning System
Antiseptic Oral Rinse Solution
* Please review the disclaimer below.
