Hi Mycin!
First, for the easy part of your question - here is a great link to a portion of the FDA's website that actually provides access to each and every OTC monograph that the agency has seemingly ever published as well as links to the actual Federal Register notices after each jump to the monograph:
http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/over-the-counterotcdrugs/statusofotcrulemakings/default.htm
As to the second part of your question, my opinion is that an antimicrobial can almost always be used for preservation of the product at sufficient levels. These levels are typically somewhat lower than the level needed for active ingredient status. Therefore, unless the material is considered to be a banned ingredient according to the regulations themselves found at 21 CFR 700.11-700.23 it could still be in there. However, there does not appear to be any specific prohibition currently based on what I just found here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
using the 21 CFR 700 search.
So overall, if no claim is made, and the level of the ingredient is below the "safe and effective" active ingredient level, then I would suggest that the material could at least in theory be used in the product. Again, this is entirely an opinion but based on the fact that the FDA has not seen fit to specifically prohibit the material and the level of the ingredient is below that of "active therapeutic" levels, it would seem acceptable. But I would simply ask the question of your team - what is the purpose/function of this ingredient in the formula? If there is a scientifically sound and justifiable purpose, then you can also document that determination which will assist in the event of questions from the agency.
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
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Original Message:
Sent: 11-03-2014 20:46
From: Mei-Yin Chiu
Subject: Cosmetic VS OTC
Dear all,
Thanks a lot for the reply and help. However, i would like to ask if the product contain very low percentage of Chlorhexidine gluconate (less than 0.1%), will it make a difference in differentiating it as a cosmetic or OTC/drug when the product did NOT make any claim or implying any antibacterial properties by presentation? Or it is an all-or-none scenario that whenever Chlorhexidine gluconate is intentionallly added, regardless how low the percentage, it is still an OTC / drug? As i find the normal use of this active ingredient in antimicrobial skin product would have to be 4% or more.
BTW, sorry but would you let me know the website/ link for the FDA monography of active ingredeint of chlorhexidine gluconate? Thanks again.
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Mycin Chiu
Cosmetic and Personal Care
Hong Kong
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Original Message:
Sent: 10-26-2014 22:53
From: Mei-Yin Chiu
Subject: Cosmetic VS OTC
Dear Forum,
If a soap containing less than 0.1% of chlorhexidine glucoate, will it be considered as a cosmetic or OTC? Will it make a difference if it is named as "antibacterial" soap and/or making claim like kill 99.9% of bacterial in the packaging? Many thanks.
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Mycin Chiu
Cosemtic and Personal Care
Hong Kong
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