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HAIR GROWTH LOTION
Hi!
I am formulating a hidro-alcoholic transparent lotion for hair growth. The thing is that using as a conditioner a Polyquaternium in the stability test at 5 month the sample I had to 40ºC get cloudy. Can anyone suggest me a conditioner or any raw material that facilitate the spreadibility?
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5 Replies
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Ingredients please?
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Would be an OTC and an unauthorized drug in the US.
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Drug status depends upon claims.
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Had this discussion with the FDA just last week. You can’t just not make a claim, include an active and believe that the products is not a drug. Here is a verbatim comment the FDA Inspector made to a new client regarding this myth;
- Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.
The client included a well-known acne ingredient in their product and didn’t make any claims whatsoever. Remember, if you expect to make an implication (hint, hint, wink, wink) and expect your customers to get the inference (wink right back), the FDA which deals with these issues frequently will not miss out on the inference and will intervene.
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This is laid out very specifically in their regulations. If an ingredient is well-known, just the presence of it on the ingredient label has the effect of making a claim. You could not, for example, put penicillin into a cream without it being a drug.
And further, since it’s up to the FDA to decide if an ingredient is well known enough to trigger this provision, it’s safer to stay on the side of the angels.
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