labeling for balms and ointments?

[krissy]

i want to make a baby line and wanted to make something that is good for diaper rash. i have tried to find out what the labeling regulations are but i am not quite understanding everything.

if i were to use ______, ________, and _______ for the purpose of putting on a baby behind for diaper rash how do i label it? can i say it is intended for preventing and or treating diaper rash if i follow labeling instructions for cosmetic or drug? what are the label instructions for that?

 

[Tabitha]

preventing and or treating diaper rash

That statement makes it a drug.

If you use a statement like... "To keep your baby's bum soft and happy ( :? )...." or somthing like that, it is a cosmetic.

 

[Tabitha]

Here is a link to the FDA links that can help you w/ labeling.

http://soapmakingforum.com/forum/viewtopic.php?t=4212

 

[krissy]

so from what i am understanding, if it had as the main ingredient OO then i would use the

(a) CTFA COSMETIC INGREDIENT DICTIONARY
(b) UNITED STATES PHARMACOPEIA
(c) NATIONAL FORMULARY
(d) FOOD CHEMICAL CODEX
(e) USAN AND THE USP DICTIONARY OF DRUG NAMES
THE NAME GENERALLY RECOGNIZED BY CONSUMERS
THE CHEMICAL OR TECHNICAL NAME OR DESCRIPTION
...right? so where do i find out what that is? is it the same as the NIST??
this is still confusing but i am trying to go a little bit at a time.

 

[Tabitha]

I make sure none of my claims fall into the realm of 'drug' so I do not have to label it as such. I do not have 'drug' experience, sorry.