Antiseptic Oral Rinse Mouthwash
FDA Label NDC 53462-175

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 Antiseptic Oral Rinse (NDC 53462-175). 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 active ingredient, purpose, use, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Cetylpyridinium chloride .05%

Purpose

Antiseptic Rinse

Use

Helps reduce chance of infection in minor oral irritation.

Otc - Stop Use

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

  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab.  Instruct to expectorate.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

Call toll free 800-323-2220

Antiseptic Oral Rinse

Aor Packet (R5267c Aorpacket)

Aor Packet (R5267c Aorpacket)

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