Qcare
FDA Label NDC 53462-308

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 (NDC 53462-308). 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?, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient: Purpose
CORINZ ANTISEPTIC CLEANSING AND MOISTURIZING ORAL RINSE:
Cetylpyridinium chloride 0.05%Antiseptic Rinse

Uses

  • Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.

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

    Toothette Oral Care Suction Toothbrush
  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • 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.
    • 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.
        • Toothette Oral Care Suction Swab
      • Before opening, turn package over, burst solution packet with thumbs.
      • Peel lid to open.
      • 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.
        • 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.

Inactive Ingredients

Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose, citric acid, sodium saccharin, menthol.

Questions?

Call toll-free 800-323-2220.

Other

LATEX FREE • FOR SINGLE USE ONLY • MADE IN U.S.A.

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