Important Changes to Directions for Use for Antiseptic Skin Cleansers

By: Jacqui Jenskey, DIRECTOR OF REGULATORY AFFAIRS, email

The Natural and Non-prescription Health Products Directorate (NNHPD) has recently revised the Antiseptic Skin Cleanser Monograph, which means manufacturers and product licence holders must make changes to the Directions for Use on their products. This update affects handrubs, wipes, and handwash products, and all changes must be implemented in both English and French.

Key Changes to Directions for Use:

For Handrubs and Wipes:

• Supervise children when they use this product.
• For occasional and personal domestic use.
• Rub thoroughly into hands for at least 30 seconds.
• Allow to dry.

Additional Guidance

1. All Products:
   • Supervise children.
   • Not for use in healthcare or food-handling premises.
2. Handrub and Wipe Products with at least 70% Ethanol or Isopropanol:
   • Apply liberally over all hand surfaces and rub thoroughly for at least 30 seconds until dry.
   • For occasional use when water and soap are not available.
3. Handrub and Wipe Products with less than 70% Ethanol or Isopropanol:
   • Apply liberally, rub for at least 30 seconds until dry, and repeat if necessary until 3 mL (x pumps) have been applied.
   • For occasional use when water and soap are not available.
4. Handwash Products:
   • Lather with water for at least 30 seconds.
   • Rinse well.
   • For occasional use.

Implementation Timeline

Product License holders are expected to align their product labels with the revised monograph within three years or during the next label run or post-licensing change (amendment or notification), whichever comes first.

At Dell Tech, we are ready to support you through this transition and ensure your products meet the updated requirements. Reach out for assistance with the labelling updates or any other regulatory support you may need!