With so many PE sprays and creams available today, I’ve often wondered why one product uses benzocaine and another product uses lidocaine. I’ve done some research and will probably do even more later as I have discovered it’s fairly complex. But this blog post will give you a basic understanding.
I’ve looked at a lot of the PE sprays, creams and gels on the market and the one thing that I’ve noticed is that the cheaper, less popular sprays use benzocaine and the more expensive sprays use lidocaine. Why is that?
Like most things, it comes down to – you guessed it – MONEY. When making a premature ejaculation spray, you need to follow the FDA monograph 21 CFR 348.10. The very first thing is your choice of active ingredients. Here’s an excerpt from the monograph about your choice of active ingredients:
The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:
(a) Male genital desensitizers. (1) Benzocaine, 3 to 7.5 percent in a water-soluble base.
(2) Lidocaine in a metered spray with approximately 10 milligrams per spray.
So, with benzocaine, all you need to do is buy benzocaine powder, put it in water or other ingredients that may be used in thousands of skin creams and lotions, at a solution of 3 to 7.5 percent – that’s sounds easy. Turns out it’s easy to buy benzocaine. Just search “benzocaine powder”. You’ll find it on Amazon, eBay and elsewhere.
You can also find lidocaine powder on-line, but the monograph requires creation of the solution in a way that it can deliver 10mg of lidocaine per spray. Way more difficult. More development, a special spray bottle, more quality control. Overall more cost.
No surprise that there are more than 50 benzocaine-based PE sprays and creams available on the market.
Why does the FDA Monograph Require Lidocaine to be Delivered in a Metered Dose Bottle?
Toxicity. Lidocaine is a stronger anesthetic. It starts to become toxic at around 300mg for an average size man. So, using the metered dose bottle, that’s 30 sprays. That’s why the monograph requires the directions to say “maximum 10 sprays”.
Here’s an article from ESBA Laboratories about topical anesthetics that well written and easy to understand: www.esbalabs.com/how-do-skin-numbing-topical-anesthetics-work.html Here is an excerpt from this article, slightly altered for faster reading.
The FDA regulates the concentration and combinations of active principles that can be used in over-the-counter analgesic drug products. These products can be sold without a medical prescription. This information is published in the Code of Federal Regulations, Title 21 (see below).
Combinations of members of the “caine” family are not allowed without a prescription. That is the reason why EMLA cream that contains a combination of Lidocaine (2.5%) and Prilocaine (2.5%) is not an OTC preparation in the US. Preparations containing Benzocaine can contain up to 20% of drug, whereas the maximum concentration of Lidocaine allowed for over-the-counter use on the skin is 4%. This reflects the relative potency of the drugs, since benzocaine is less potent and very poorly absorbed even through mucous membranes.
FDA Monograph 21 CFR Part 348