The US FDA currently believes that the safe and effective active ingredients used as antibacterial hand sanitizer are ethanol (60-95%), isopropanol (70-91.3%), and benzalkonium chloride.
On April 12, 2019, the U.S. Food and Drug Administration (FDA) released the final rules for the safety and effectiveness of antibacterial hand sanitizers for consumer use, which involves the final rules for OTC consumer wipe-free antibacterial products.
Certain active ingredients used in OTC consumer antibacterial products (OTC non-rinse antibacterial hand sanitizer) that are not used with water are not currently eligible for OTC drug review and evaluation. Therefore, drugs containing these unqualified active ingredients need to be approved by the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) before marketing.
The effective date of the rule is April 13, 2020, which will take effect one year after the date of issue.
The following table lists the active ingredients that can be used in OTC consumer non-rinse antibacterial products in the OTC drug review, and provides the 1994 TFM proposal and the 2016 regulatory proposal for consumer non-rinse antibacterial products.
In the 1994 TFM, ethanol was classified as Class I, isopropanol was classified as Class IIIE, and benzalkonium chloride was classified as Class IIISE for antibacterial hand washing or medical staff hand washing. However, in the 2016 regulatory proposal, the FDA recommended that all three ingredients be classified as IIISE for consumer antibacterial products, as more effective and safety data are needed to confirm the three active Whether the composition is GRAS / GRAE.
At present, the FDA has postponed further regulations for the three active ingredients, benzalkonium chloride, ethanol and isopropanol. However, the safety and effectiveness data of these three ingredients will continue to be developed and submitted to confirm whether they are considered safe and effective for use in OTC non-rinse antibacterial products. If these studies are not completed, the current market status will be maintained for the time being and will be resolved after the completion and analysis of the study or at other times. Currently, the FDA does not intend to take measures to remove hand sanitizers containing these three active ingredients from the market.
Therefore, as far as the current situation is concerned, the effective active ingredients on the market that can be used for antibacterial products are ethanol (60-95%), isopropanol (70-91.3%), benzalkonium chloride.
The following list is the active ingredients that are not qualified for rubbing disposable antibacterial products (including the active ingredients used in antibacterial hand sanitizers or health antibacterial hand sanitizers in the TFM 1994. And consumer rubbing disposable antibacterial products in 2016 Active ingredients identified in the regulatory proposal. Eligibility evidence evaluated based on OTC drug review is not sufficient for OTC wipe-off anti-bacterial products):
Ø benzethonium chloride
Ø Chlorhexidine gluconate
Ø Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
Ø Iodine complex (alkylaryloxy polyethylene glycol phosphate)
Ø Mebenzol ammonium chloride
Ø Nonylphenoxy poly (ethyleneoxy) ethanol iodine
Ø Phenol (equal to or less than 1.5% or greater than 1.5%)
Ø Poloxamer (Iodine Complex)
Ø Povidone iodine (iodine) (5% to 10%)
Ø Sodium Oxychlorobenzene Sulfonate
Ø Triple dye
Ø Endinium chloride iodine complex
In addition, the FDA received several submissions in response to the 1994 TFM, as previously stated in the 2016 Proposed Antibacterial Products Regulations. The following compounds are required to be included in the monograph on unqualified ingredients:
Ø Polyhexamethylene biguanide
Ø benzalkonium hexadecyl phosphate
Ø Salicylic acid
Ø Sodium hypochlorite
Ø Tea tree oil
Ø Combination of potassium vegetable oil solution, phosphate chelator and triethanolamine
The main active ingredients of leave-in antibacterial hand sanitizers are alcohol, isopropanol or benzalkonium chloride. Bacteriostatic effects are alcohol, isopropanol and benzalkonium chloride. After washing your hands, it can volatilize automatically without running water. Therefore, anti-bacterial hand sanitizers on the market generally add anti-bacterial active ingredients and some volatile solvents. After use, they can both inhibit bacteria and sterilize, and can also achieve the purpose of no-wash. At the same time, in order to protect the skin, skin care ingredients such as glycerin, vegetable oil, and lipids are also added. It can be said that bacteriostatic active ingredients + volatile solvents + skin care ingredients are the basic constituents of non-rinse antibacterial hand soap.
Alcohol and isopropyl alcohol are common fungicides and solvents in cosmetics and other fields. At present, most non-sanitizer hand sanitizers on the domestic market can be divided into two types: foam type and non-foam type. Most of the foam-free products are gel-like, with an active ingredient of more than 55% ethanol, and some products even have an ethanol content of more than 90%. However, the higher the ethanol content, the better. Ethanol needs a certain amount of water to exert its bactericidal effect. If the concentration is too high, it is not conducive to the penetration of ethanol into the microorganisms and affect the sterilization effect. The concentration is too low, and although easy to penetrate, it does not reach the sterilization dose. In general, 65-80% ethanol has the strongest bactericidal effect, and only has a bacteriostatic effect when the concentration is lower than 50%. Carbohydrate, glycerol, propylene glycol, water, plant extracts and other auxiliary materials are also added to the hand sanitizer system. In this type of system, there are also products added with 0.1% (w / w) benzethonium chloride fungicide.
Another type of product is foam type. Foam type antibacterial hand sanitizer is mainly composed of bacteriostatic active ingredients and surfactants, and other moisturizing and emollient ingredients are added to protect the skin. The antibacterial active ingredients of this kind of hand washing liquid are mainly benzalkonium chloride, benzethonium chloride and chlorhexidine gluconate.
Caution: Flammable. For external use only. keep out of reach children. avoid contact with eyes and broken skin. if product gets into eyes, rinse with water thoroughly. stop using this product if skin irritation occurs and consult a doctor immediately.
In addition, alcohol-based hand sanitizer contains a large amount of alcohol, which has a strong degreasing effect. Occasional use does not hurt much. If used regularly, it will damage the oily layer on the skin surface, cause skin cracking, and it is not suitable for people who are allergic to alcohol. And because of the high volatility of alcohol, the product will gradually evaporate over time after long-term use, affecting the antibacterial ability of the product.