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How to Pick a Safe Hand Sanitizer

Not all hand sanitizers are created equal. As countless companies have started selling various versions of hand sanitizer, the market has become a kind of “wild west” in terms of ingredients and safety. In June 2020, the FDA (United States Food & Drug Administration) issued a widespread recall of hand sanitizers containing the toxic chemical methanol, a potentially deadly ingredient if ingested, inhaled, or absorbed through the skin.1 How did this happen?

TEMPORARY DE-REGULATION OF SANITIZER MANUFACTURING

The COVID pandemic of 2020 has resulted in a very high demand for hand sanitizer, causing the FDA to temporarily allow non-drug manufacturers to produce their own hand sanitizers using the FDA’s strict ingredient guidelines.2 Unfortunately, some companies did not follow the protocols, which has resulted in hand sanitizers being sold to the public despite potentially being filled with dangerous ingredients, including methanol. As of July 23, 2020, ten deaths have already been linked to methanol in hand sanitizers.3

THE SMELL TEST

Aside from dangerous methanol, many consumers are reporting a strong “tequila” smell in their hand sanitizers. Is this safe? Does it mean there’s actual tequila in them? Or is this related to methanol? It all comes down to the specific chemical grade of the alcohol base. If your hand sanitizer smells like tequila, rotten garlic, or sour onions, you might be dealing with a fuel-grade alcohol.

FUEL VS. FOOD-GRADE ALCOHOL

Because people are driving much less than usual due to the Coronavirus pandemic, some companies have excess stores of fuel-grade alcohol in their warehouses that would otherwise be used to make fuel/gasoline. It is possible that some of these excess stores are being used in the manufacture of hand sanitizer instead, as the FDA has granted this temporary permission due to high demand for hand sanitizers. It is possible that some companies rushed to market in order to achieve a quick profit without properly refining their fuel-grade alcohol, which may contain traces of toxic methanol and other carcinogens that can lead to serious health problems after prolonged exposure. As stated by FDA commissioner Stephen Hahn, “Unfortunately, there are some companies taking advantage of the increased usage of hand sanitizer during the coronavirus pandemic and putting lives at risk by selling products with dangerous and unacceptable ingredients.”3

Although it comes from a neutral grain alcohol called ethanol, fuel-grade alcohol is not the same as purified ethanol approved for human use. It is NOT refined, NOT tested for purity, NOT authorized for topical use, NOT filtered to reduce carcinogenic compounds (including methanol), and NOT safe for personal use. It is not USP-grade, which is approved for topical (skin) use.

Fuel-grade ethanol is intended for industrial use only (particularly gasoline), and is not approved for human consumption or personal use (as in hand sanitizers). A strong tequila smell in your hand sanitizer may be an indication of fuel-grade ethanol, which has not been highly refined to remove chemical residue and toxins.

THE RX CLEANSE DIFFERENCE

Rx Cleanse hand sanitizers use only pharmaceutical-grade (USP) ethanol, which is a food-grade, highly-refined version of ethyl alcohol that is approved for human consumption. It is safe, highly-filtered, effective, tested for purity, ultra-refined, and industry-approved for topical or internal use. The ethanol used has a neutral odor, which is verifiable proof of its high filtration process, and therefore does not smell of tequila or rotten garlic.

RX CLEANSE IS:

  • Made with the highest USP-Grade ingredients
  • Manufactured in an FDA-registered facility
  • Produced using current good manufacturing practices (CGMP)
  • Registered as an approved Over the Counter (OTC) Drug Manufacturer
1 Gallon Bottle RXCleanse Hand Sanitizer

Premium antibacterial hand sanitizer gel, enhanced with moisturizing aloe vera, naturally antiseptic tea tree oil, and lightly scented with peppermint oil.

Made with 70% (non-toxic) Ethyl Alcohol - Above CDC Minimum Requirements to Help Eliminate Germs, Bacteria, and other Viral Pathogens, including SARS-CoV-2.


Sold out
1 Gallon Bottle RXCleanse Hand Sanitizer

Premium antibacterial hand sanitizer gel, enhanced with moisturizing aloe vera, naturally antiseptic tea tree oil, and lightly scented with peppermint oil.

Made with 70% (non-toxic) Ethyl Alcohol - Above CDC Minimum Requirements to Help Eliminate Germs, Bacteria, and other Viral Pathogens, including SARS-CoV-2.


Sold out
1 Gallon Bottle RXCleanse Hand Sanitizer

Premium antibacterial hand sanitizer gel, enhanced with moisturizing aloe vera, naturally antiseptic tea tree oil, and lightly scented with peppermint oil.

Made with 70% (non-toxic) Ethyl Alcohol - Above CDC Minimum Requirements to Help Eliminate Germs, Bacteria, and other Viral Pathogens, including SARS-CoV-2.


Sold out
1 Gallon Bottle RXCleanse Hand Sanitizer

Premium antibacterial hand sanitizer gel, enhanced with moisturizing aloe vera, naturally antiseptic tea tree oil, and lightly scented with peppermint oil.

Made with 70% (non-toxic) Ethyl Alcohol - Above CDC Minimum Requirements to Help Eliminate Germs, Bacteria, and other Viral Pathogens, including SARS-CoV-2.


Sold out

WHAT IS USP GRADE?

Also known as Food Grade, USP grade is the industry standard for safe food and drug ingredients. In general, USP refers to the United States Pharmacopeia, a large scientific organization that conveys legally-recognized quality standards of safety and dosage for pharmaceutical products and nutritional supplements. For something to be considered USP Grade, it must meet the rigorous standards set forth by the most recent food & drug laws of the United States.4 USP Grade products meet or exceed the standards set forth for food, drug, or medicinal use.5 

Rx Cleanse hand sanitizers use a 70% base of USP-certified ethyl alcohol, AKA ethanol, which means it has been tested and verified for purity, has a neutral odor, and is safe for human use. Although the ethyl alcohol in our products is food-grade (meaning the alcohol is safe enough for human consumption), hand sanitizer should never be ingested. We use food-grade (AKA USP-Grade) ethyl alcohol for its high purity, but our hand sanitizers are strictly intended for topical use. In other words, we use only food-grade alcohol as the base for our Rx Cleanse hand sanitizers to ensure maximum safety for your entire family.

RX CLEANSE IS AN FDA-REGISTERED FACILITY. WHAT DOES THAT MEAN?

All of our products are made in the United States, in a company-owned manufacturing facility that is FDA registered for food and drugs. This means that we have undergone the rigorous process of being officially registered with the FDA to be able to manufacture food and drug products that are safe for human consumption.6

WHAT’S THE DIFFERENCE BETWEEN FDA REGISTERED, APPROVED, OR CLEARED?

Rx Cleanse is manufactured in an FDA-registered facility that has undergone a stringent registration process. Being an FDA-registered facility is the highest mark of FDA safety, above FDA-Cleared or FDA-Approved.

If a product is deemed “FDA Approved,” it typically means that the FDA has determined its benefits outweigh its risks, and is therefore allowed to be sold.7 Manufacturers must still submit an application to the FDA prior to selling the cleared product, along with research study results showing the product’s proven safety and/or efficacy.

However, if a product is merely “FDA Cleared,” it means that it is similar enough to a previously-approved product to be allowed on the market without having to prove safety or efficacy. The product manufacturers do not have to perform any testing or provide research results to the FDA, but rather they merely need to show that their new product is nearly identical to another product that is already approved to be on the market.

For instance, if Product A has already been approved by the FDA, and Product B is very similar, Product B merely needs to apply to the FDA to be cleared, rather than approved, by showing that it is substantially equivalent to Product A, which was already approved and is being sold. The process is much faster and easier for the company, but less stringent in terms of safety or efficacy measures.

One potential problem with being merely “FDA Cleared” is the possibility of recalls. FDA clearance relies on a previous product (called the “predicate”) having been approved, but what happens if that original product is recalled? Newer products can still use that original product to get clearance. For instance, if the original Product A that was used as a comparison to get Product B cleared by the FDA turns out to be recalled for safety reasons, Product B can still be cleared to be sold on the market. This can and does happen, and for this reason, “FDA Cleared” is not a reliable measure of safety or efficacy.

Finally, “FDA Registered” is the most stringent process, as it requires more than just clearance or approval. To be FDA registered requires a thorough application and inspection by the FDA of a company’s manufacturing facility, as well as renewed registrations every other year8. In addition registered companies that are found to be in violation of the FDA’s regulations can be suspended by the organization, ensuring consumer safety.

Cosmetics companies are NOT required to register with the FDA, and cosmetic products are not required to receive FDA approval prior to being sold,9 which is why it’s important that your hand sanitizer comes from an FDA-registered manufacturer, not a cosmetics company. All Rx Cleanse products are manufactured in an FDA-registered facility that is also approved to manufacture food products, thereby following the strictest FDA guidelines for consumer safety.

RX CLEANSE IS CGMP COMPLIANT. WHAT IS THAT?

CGMP is defined by the FDA as “Current Good Manufacturing Practices.” It refers to the FDA’s compliance monitoring to ensure that a company meets the agency’s requirements for “the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.”10 Rx Cleanse products are manufactured in a facility that has been successfully inspected by the FDA and approved as CGMP compliant.

It is also important to note that the “C” in CGMP refers to “Current,” which means that we comply with the most recent measures of safety and efficacy. The FDA regularly updates its requirements, and in order to be CGMP compliant, Rx Cleanse meets these latest standards.

RX CLEANSE IS LICENSED AS OTC. WHY IS THAT IMPORTANT?

OTC refers to “Over the Counter,” and it refers to nonprescription drugs that are deemed safe and effective by the FDA for general medical use.11  Rx Cleanse products are manufactured in an OTC-licensed facility, which means that we have been inspected and approved by the FDA to manufacture over-the-counter products, including hand sanitizer.

This is important because it means all our products are verifiably safe and effective for personal use, and are available without a prescription. We have not taken shortcuts around legal requirements, and we follow FDA guidelines for consumer safety. Our top priority is to provide safe, effective, and reliable products that your whole family can use.


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