FDA Label for Qcare Oral Cleansing And Suctioning System, Q4

Drug Facts

Uses

Suction Swab with Perox-A-Mint Solution:
• Aids in the removal of secretions and debris.
Suction Toothbrush with Antiplaque Solution:
• Aids in the removal and prevention of plaque that leads to gingivitis.

Warnings

Suction Swab with Perox-A-Mint Solution:

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.

Suction Toothbrush with Antiplaque Solution:

Stop use and ask a dentist if:
• Gingivitis, bleeding or redness persists for more than 2 weeks.
• You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Otc - Keep Out Of Reach Of Children

Suction Swab with Perox-A-Mint Solution:
Keep out of reach of children.
If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Suction Toothbrush with Antiplaque Solution:
Keep out of reach of children under 6 years of age
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Suction Swab with Perox-A-Mint Solution:
• 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 with Antiplaque Solution:
• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• Remove Mouth Moisturizer and Applicator Swab.
• 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.
• Place Mouth Moisturizer on Applicator Swab.
• Apply as needed to lips and inside mouth.
• Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
• Children ages 6 to 12 years: supervise use.
• Children under 6 years of age: do not use.
• 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.

Inactive Ingredients

Suction Swab with Perox-A-Mint Solution:
Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Suction Toothbrush with Antiplaque Solution:
Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

Package Label.Principal Display Panel

Q·Care^® Oral Cleansing and Suctioning System

R4699B_6504_bag1 - R4699B 6504 bag1

Q·Care^® Oral Cleansing and Suctioning System Label

Q-Care^® Oral Cleansing and Suctioning System, q4°