1. Home
  2. Labeler Index
  3. Sage Products Llc
  4. 53462-120
  5. Label Information: Toothette Oral Care Single Use System With Antiseptic Oral Rinse

FDA Label for Toothette Oral Care Single Use System With Antiseptic Oral Rinse

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USES
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS*
    7. QUESTIONS?
    8. OTHER
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Toothette Oral Care Single Use System With Antiseptic Oral Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Sage Products Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.