Teach Soap

I have been making my own hand sanitizer with aloe vera gel, witch hazel, and a combo of essential oils. I wanted to sell it, but because of the 14 percent alcohol in the witch hazel I presume I would not be anle to with certain permits and licenses. But whT if I purchase witch hazel without alcohol in it, because after all the essential oils are whats sanitizing. And then labeled it something such as hand gel, or something that didnt say kills germs, but more of just a gel for your hands. Would this be legal? I cant find any information about it online. Any help would be really appreciated.

Thanks!

Hand sanitizer is an over the counter drug. So if you call it something else, now you have to ask yourself, what are the customers going to expect this product to do?

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Genny

Well say I wished to sell it as hand sanitizer? Would it be something as simple as putting a warning, etc on the label? Or would it be more extensive such as getting a permit?

Before putting it out on the market, you'd have to have it tested and send those findings to the FDA. There's a lot more that goes into it, including following Good Manufacturing Processes & such. Here's some info about it
http://www.fda.gov/Drugs/DevelopmentApp ... efault.htm
http://www.fda.gov/Drugs/DevelopmentApp ... efault.htm

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Genny

If you used witch hazel without the alcohol, you will definitely need a preservative. The 14% in the witch hazel gets diluted with the aloe vera gel and the essential oils, so it's no longer at 14% strength. Does the aloe gel have a preservative? The way I understand it, the formula need to have at least 20% pure alcohol in order for the formula to be preserved. I would get it tested before you do any selling.
Essential oils do have antiseptic properties, but they do NOT act as preservatives in a formula that's water based (aloe vera gel).

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Irena
Closed minds are like faulty parachutes; they refuse to open.

Well Aloe Vera and other essential oils will definitely serve as good sanitizer so can't you make it without adding the alcohol stuff and by just using the natural products.

A hand sanitizer and other drugs are required to divide the panel into active and non-active ingredients, and list the %'s. The entire panel set up is different than cosmetics, but you can find the requirements on the FDA website. Where you will run into your biggest issue is the active ingredient part. You will need to test your product and give (with proof to back it up) a % of germs killed. Hand sanitizers are rated on their panels. People really need over 86% for a cleanser to be effective, but some are 99% and some are as low as 65%. At any rate, you also need to know the % of active ingredient(s) for your panel. While the US does not currently recognize eo's as drugs, if you are asserting that they are the active ingredient, you will need to back that up with lab tests to prove it (as you would even if you were using a classified drug as the active ingredient).

While you may feel that the eo's offer enough antibacterial properties to cover your recipe/batch, you still need to test them. You cannot say, advertise, or in any way cause a customer to think that the product is a sanitizer unless you follow all the rules for that product. Unfortunately most people assume that just because an eo has some antibacterial properties, it will preserve their product. This is very often not the case. In order to preserve you need a broad spectrum antibiotic, antimicrobial , antifungal and yeast inhibitor. Even if you have an eo or an eo blend that has all those properties, do you have the properties in an amount sufficient to preserve the product, cover the batch? Can you add enough to work without irritating the skin? And if you can, how long will they last/work?

While I am a proponent of herbal and essential oil remedies, I think a good many people just read a bit and then think they know all they need to know about it. I have found that many do not even know that there is a limit to the % of each eo that should be used in any recipe/formulation, and that that % changes with the product being made. SO you may be able to put 5% of a certain eo into soap, but only 2% of that same eo may be used in a lotion. And you certainly cannot put 15% eo's into a recipe when the rate is 5% for each of the three eo's you are using in a blend. If you are aware of this and are a well educated crafter, then my statement does not apply to you, but it does apply to many, so I leave it stated for those that are unaware.

So,are you sure of what you have formulated and have you tested your product in a reputable lab so that you can prove what you are doing? If the answer is no, are you willing to do so and wait the necessary time? You will need to test the sample out at various months of shelf life to know when your coverage wanes. Product development for lotions and things that need preserved should take at least one year to offer a one year expiration date. A good many people make a product and begin selling without proper testing, which is not just a poor business practice, but is potentially dangerous for the customers.

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Remember, it's not just that we weather the storm, but how we dance in the rain.

Tammy

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Irena
Closed minds are like faulty parachutes; they refuse to open.

Thanks for all the information! Now one mlre question. What if I chose to make hand sanitizer with alcohol in it? At say 70 percent? How would I go about selling this? And labeling? Would it need extensive testing as eell? Im sorry if it was already answered. I just need clarification.

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Irena
Closed minds are like faulty parachutes; they refuse to open.