1. Home
  2. Labeler Index
  3. Sage Products Llc
  4. 53462-201
  5. Label Information: Short Term Oral Swab System

FDA Label for Short Term Oral Swab System

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USE
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS
    7. QUESTIONS
    8. OTHER
    9. SHORT TERM ORAL SWAB SYSTEM WITH PEROX-A-MINT SOLUTION

Short Term Oral Swab System 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 Purpose
 PEROX-A-MINT SOLUTION:
 1.5% Hydrogen peroxide Oral debriding agent


Use



Aids in the removal of debris and secretions.


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 debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Dip an Oral Swab into the Perox-A-Mint solution.
  • Clean teeth and oral cavity for approximately 1 minute.
  • Instruct to expectorate.   
  • Apply Mouth Moisturizer as needed.
  • Discard after use.
  • Swabs are intended for single oral use only.
  • 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, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI42090), Yellow 6 (CI15985)


Questions



Call toll free 800-323-2220


Other



MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX


Short Term Oral Swab System With Perox-A-Mint Solution



Short-Term Oral Swab System Reorder #6000

NDC: 53462-201-30

Short Term 6000 bag - ShortTerm 6000 R4561F bag

Short Term 6000 bag - ShortTerm 6000 R4561F bag

Perox-A-Mint Reorder #6065

NDC: 53462-075-30


* Please review the disclaimer below.