Qcare Oral Cleansing And Suctioning System, Q4
FDA Label NDC 53462-504

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 53462-504). 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?, package label.principal display panel, 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 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)

R4699b_6504_bag1 (R4699b 6504 Bag1)

Q·Care® Oral Cleansing and Suctioning System Label

R6037_6504_overlabel2 (R6037 6504 Overlabel2)

R6037_6504_overlabel2 (R6037 6504 Overlabel2)

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

R5427_top_web_film_6504 (R5427 Top Web Film 6504)

R5427_top_web_film_6504 (R5427 Top Web Film 6504)

* Please review the disclaimer below.