Toothette Oral Care Single Use System With Antiseptic Oral Rinse
FDA Label NDC 53462-120

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 Toothette Oral Care Single Use System With Antiseptic Oral Rinse (NDC 53462-120). 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:
ANTISEPTIC ORAL RINSE*:		Purpose
Cetylpyridinium chloride .05%Antiseptic Rinse

Uses

  • Helps reduce the chance of infection in minor oral irritation.
  • Aids in the removal of debris.

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

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Clean teeth and oral cavity for approximately one minute.
  • Instruct to expectorate.
  • Repeat cleaning with other swab as needed.
  • Discard after use.
    • 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, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue No. 1.

Questions?

Call toll-free 800-323-2220.

Other

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

* Manufactured for Sage Products LLC

Package Label.Principal Display Panel

Toothette Oral Care Single Use System with Antiseptic Oral Rinse

NDC 53462-120-60

* Please review the disclaimer below.