Qcare Petite Size Oral Cleansing And Suctioning System
FDA Label NDC 53462-714

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 Petite Size Oral Cleansing And Suctioning System (NDC 53462-714). 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?, mouth moisturizer ingredients*, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Suction Swab, Petite Size, with Antiseptic Oral Rinse/Suction Toothbrush, Petite Size, with Antiseptic Oral Rinse
Active Ingredient:
ANTISEPTIC ORAL RINSE:
Purpose
Cetylpyridinium chloride .05%Antiseptic Rinse

Uses

    Suction Swab with Antiseptic Oral Rinse
  • Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.
    • Suction Toothbrush with Antiseptic Oral Rinse
    • Aids in the removal of dental plaque, secretions, and debris; helps reduce the chance of infection in minor oral irritation.
      • Oropharyngeal Suction Catheter
      • Aids in the removal of secretions from the oropharyngeal cavity only.

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 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.
    • Suction Toothbrush 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 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.
        • Oropharyngeal Suction Catheter

          • 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.
          • CAUTION:

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

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

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* Please review the disclaimer below.