Qcare Oral Cleansing And Suctioning System, Q4
FDA Label NDC 53462-804

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 53462-804). 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, inactive ingredients, questions?, qcare oral cleansing and suctioning system, q4, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient: PEROX-A-MINT: Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent
Active Ingredient: ANTIPLAQUE*: Purpose
Cetylpyridinium chloride .05%Antigingivitis/antiplaque

Uses

Suction Swab with Perox-A-Mint:
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.

Oropharyngeal Suction Catheter:
Aids in the removal of secretions from the oropharyngeal cavity only.

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 Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Swab. Reattach Covered Yankauer to Suction Handle.
  • 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 Handle.
    • Clean teeth and oral cavity for approximately one minute.
    • To suction, slide switch to ON. When finished, return switch to OFF.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard Toothbrush. Reattach Covered Yankauer to Suction Handle.
    • 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 Cather to Suction Handle.
      • Suction secretions from the oropharyngeal cavity.
      • To suction, slide switch to ON. When finished, return switch to OFF.
      • To clear tubing, rinse with sterile saline or appropriate solution.
      • Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
      • Use a 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 practicioner.

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

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

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* Please review the disclaimer below.