Hand Rub Formulations During COVID-19 Pandemic

June 05, 2020

Hand Rub Formulations During COVID-19 Pandemic

The FDA recently released a temporary policy and provided guidance regarding consumer hand rub formulations during the Covid-19 emergency.

Formulated products are required to meet certain criteria. They recommend that hand sanitizer and personal hand rub products are manufactured using specific ingredients. The following ingredient list is one of them, which is also consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (formulated to 80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution.
  • Glycerin (glycerol) (1.45% v/v)
  • Hydrogen peroxide (0.125% v/v)
  • Sterile distilled water or boiled cold water

Mia’s Botanicals recognizes that there is a shortage of hand sanitizers during this pandemic and people are looking for ways to produce their own sanitizers for use in their homes.

Hand sanitizers and hand rubs are not as effective as soap and water. If you need to leave your home, consider bringing soap with you.

If soap and water is not available, use hand-sanitizing products that contain the ingredients as recommended.

Consumers are reminded to keep hand sanitizers out of the reach of children and, in case of ingestion, to get medical help or contact a Poison Control Center immediately. Very small amounts of hand sanitizer can be toxic, even lethal, to young children.

 

More info from the FDA:

Additional Considerations for Ingredients in Preparation of the Product: Alcohol (ethanol) 15 that is produced using fermentation and distillation processes typically used for consumable goods, and that is made in a facility used for producing consumable goods, may be considered for use in hand sanitizer. Alcohol derived from synthetic processes may be considered for use in hand sanitizer only if it meets USP or FCC16 grade. Alcohol produced in facilities normally producing fuel or technical grade alcohol (ethanol) may be considered for use in hand sanitizer provided the following circumstances are present: (i) the alcohol is produced using fermentation and distillation processes typically used for consumable goods, and no other additives or other chemicals have been added to the ethanol;

In response to the demand for alcohol-based sanitizers, certain entities that are not currently regulated by FDA as drug manufacturers have requested guidance on the preparation and distribution of hand sanitizer products for the public’s use. Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided these entities are following the temporary policy as outlined.




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