Qcare Oral Cleansing And Suctioning System, Q4
FDA Label NDC 53462-424

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, Q4 (NDC 53462-424). 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, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, uses, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Suction Swab with Perox-A-Mint® Solution 
Active Ingredient Purpose
 PEROX-A-MINT
 Hydrogen peroxide 1.5% Oral debriding agent

 Suction Toothbrush with Antiplaque Solution
Active Ingredient Purpose
 ANTIPLAQUE
 Cetylpyridinium chloride .05% Antigingivitis/antiplaque

Use

  • Aids in the removal of secretions and debris.

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 of worsens.
  • 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

Keep out of the reach of children.
If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of the 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

  • 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.
    • Oropharyngeal Suction Catheter:

      • 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 bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
      • Caution

        • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practitioner.

Inactive Ingredients

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).

Uses

Suction Toothbrush with Antiplaque Solution:

  • Aids in the removal and prevention of plaque that leads to gingivitis.
  • Oropharyneal Suction Catheter packages:

    • Aids in the removal of secretions from the oropharyngeal cavity only.

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products, LLC Cary, IL

NOT MADE WITH NATURAL RUBBER LATEX. FOR SINGLE USE ONLY. MADE IN U.S.A.

Qcare Oral Cleansing & Suctioning System, Q4 Reorder#6424

Qcare 6424 (Qcare 6424 R4679b Bag)

Qcare 6424 (Qcare 6424 R4679b Bag)

Qcare 6424 Film (Qcare 6424 R5343b Film)

Qcare 6424 Film (Qcare 6424 R5343b Film)

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Qcare 6424 Drug Facts (Qcare 6424 R5343b Film2)

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