Elyptol Antimicrobial Rub
FDA Label NDC 69343-221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elyptol Inc. for the product Elyptol Antimicrobial Rub (NDC 69343-221). 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 ingredients:, purpose, keep out reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Ethyl Alcohol 70% v/v

Purpose

Skin antiseptic

Keep Out Reach Of Children

  • Supervise children under 6 years.
  • Not recommended for infants.

Uses

  • To decrease bacteria on skin.
  • Recommended for repeated use.

Warnings

  • For external use only

    • Flammable.

    • Keep away from sources of fire or flame.
    • If swallowed seek medical advice or contact a Poison Control Center, immediately.

      • When using this product

      • Do not ingest or inhale.
      • Keep away from eyes.
      • Use undiluted.

        • Stop using and ask a doctor

        • If redness or irritation develops.
        • In case of eye contact, rinse eyes with water.
        • If issues persist, seek medical attention.

Directions

• HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds.
• SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails.
• PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds.

Other Information

Store below 30°C
Keep out of direct sunlight.

Inactive Ingredients

Eucalyptus oil, Water, Glycerol, Cellulose, Piroctone Olamine.

Questions?

(866)701-8344

Packaging

Image Description (Elyptol)

Image Description (Elyptol)

* Please review the disclaimer below.