Anti-lice shampoo

Amira

Hello everyone, 
Does anyone try to make an anti-lice shampoo using benzyl benzoate? 
I am considering it, but i can't get the percentage of its usage. 

Username

Following this thread.?

I am looking into formulating anti-lice for syndet.
most products I found labeled with Anti-lice only contains Neem extract, Madre de cacao and tea tree essential oil. I wonder if these ingredients would suffice?

Microformulation

Is this for a market? If so, you are limited to the actives, concentrations and dosage forms approved by the OTC Monograph, of which Neem is not approved.  

Microformulation

https://www.federalregister.gov/documents/2002/05/10/02-11656/pediculicide-drug-products-for-over-the-counter-human-use-proposed-amendment-of-final-monograph

amitvedakar

PERMETHRIN 1% Shampoo/rinse. perhaps It is Pharma Product.

carplgrower

Hello;
In my country there is a anti-lice soap and shampoo which contain "camphor". It is traditional treatment and it is very effective.

It must be otc ingredients all over the world.

Soexcited

It looks like because of growing pesticide resistance in lice, the US is moving towards dimethicone. Which other countries have been using for quite some time 

Microformulation

Dimethicone?

carplgrower

@Microformulation, dimethicone cover the lice body and plug their respiratory holes. So lices are drowning.

But if I remember correctly it can only use as hair lotion, not as shampoo. Because it must be sit on scalp 5-8 hours.

Microformulation

That is not really approved under the OTC monographs nor is it anything I was ever exposed to in Retail Pharmacy. Can you post a link to a US product?

Soexcited

I found it in a study, not a product 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4475297/

Microformulation

That does not authorize it for OTC. In the US, actives must be specifically allowed in the monograph.

Soexcited

Thank you for sharing that information with me and giving me the correct terminology @Microformulation I'm incredibly new at all of this. And I knew regulations were handled by the FDA, but I didn't know that regulations of active ingredients were called monographs.

Once upon a time I was working towards being a research biologist in cellular biology. Searching for papers on various things that tickle my brain is still something I do quite often.

A 4% dimethicone(dimeticone) product that's left on for 15 minutes I believe is commonly used in the UK and NZ. I wonder if it would be worthwhile for someone to file to have it used similarly here? 

And I sincerely apologize if the information I shared was misleading 

Perry

@Soexcited - the fact that no one has done that yet suggests that it is not worthwhile enough from a business standpoint to incur the expense of getting on the monograph.

Microformulation

@Soexcited Never feel that you have to apologize for not knowing something. This blog is at heart a learning tool and believing that you have learned it all often becomes a barrier to learning. So, don't apologize for being intellectually honest. If you approach this group with that in mind, you will gain a great deal of knowledge and many of the Professionals will weigh-in.

The best way to explain the monograph system is this. First, learn the FDA Definition of a Cosmetic; "FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Notice that the definition has a strict "line in the sand", that being that a "Cosmetic" cannot address a disease state and cannot claim a physiological mechanism of action. These are "drug claims", not Cosmetic claims. (I know, you can produce examples of lines violating this restriction, they haven't been caught and I will only be endorsing textbook answers that address 100% compliance).

So, what happens when we make a product that has a drug claim? It either becomes an Over the Counter drug or it could even become a prescription product.

The FDA has set-up a monograph system for OTC Drugs. (https://chemistscorner.com/a-list-of-cosmetics-that-have-fda-monographs/).

For some guidance on the components of a monograph; https://chemistscorner.com/otc-drug-monographs-and-cosmetics-part-2/

If you can remember that definition and have an understanding of the difference between a Cosmetic Claim and a Drug Claim, you are already more advanced than many others.

Ask questions, question the validity of ideas and not the person and in the end, you will be a great participant in the Forum.

Soexcited

@Microformulation thank you for being so encouraging!

So if a product claims to help decrease dry skin and/or protect against it, it automatically shifts to being considered an otc? And the active ingredients that add those traits to the product have to be ones the FDA have listed for those conditions and in the percentages found on the monograph?

It sounds very much like the FDA's definition of supplements and how they must be taken by mouth since they're considered food. It's rather sad, because fat soluble substances like D3 would likely have a much better absorption rate at a lower dosage if they were applied inside the nostrils

But I have strayed very far off topic.
I don't want to hijack this thread.
I will continue researching FDA regulations. Thank you again

ozgirl

I was intrigued by this as Dimethicone is commonly used in Australian lice treatments as well. The lice treatment kits contain the dimethicone treatment solution and also include a very fine toothed comb. These treatments are all listed as "medical devices" on the Australian Register of Therapeutic Goods rather than as OTC or prescription drugs.

I did find one product available in the US that uses dimethicone (https://www.walgreens.com/store/c/licemd-lice-&-egg-removal-kit/ID=prod6114800-product). Perhaps they are also being sold as medical devices rather than OTC to get around the monograph.

Microformulation

Moisturization is a Cosmetic claim. If you extrapolated that it treated eczema (and boy howdy, they do), it would become a drug claim.

Why are Cosmetics and Supplements different? Simply due to the fact that supplements are regulated by a different act and considered a separate product. They follow the Dietary Supplement Health and Education Act, (the DSEHA) not the Cosmetic Act. Remember this distinction since someday you will wrongly see someone say that they make any claims as long as they cite the DSEHA.

"the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."  https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm

The LiceMD Pesticide Free is the Dimethicone product and they use careful wording. I have read that study before, but in that case, it was cited to show that dimethicone was less effective than Permethrin in the same time period. Remember, these studies are small and often they are selectively interpreted.

In the end, my best advice is to follow the letter of the law, not what "they" are doing. Remember, LiceMD has a Regulatory expert to consult with to mitigate liability.

Amira

Thank you all for your input here. I found it so useful and valuable. 
But what about using deet99 ? 

Username

A good read for me! thank you all