If it is a drug
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The third category, reached from soap by a small number of very common words.
The claims that get you here
- Antibacterial. Antimicrobial. Kills germs.
- For acne. For eczema. For psoriasis. For dermatitis.
- Healing. Treats. Relieves. Prevents.
- Antifungal. Medicated.
Each represents the product as treating or preventing a condition, or as affecting the structure or function of the body, which is the statutory definition of a drug.
And note what is not required: the product does not have to contain anything active. The claim alone puts it there.
What a drug requires
An active ingredient from the relevant OTC monograph, at a monograph concentration.
A Drug Facts panel in the prescribed format.
Establishment registration with FDA, an NDC labeler code and drug listing.
Manufacture under cGMP, 21 CFR Parts 210 and 211, which is a pharmaceutical standard with no small-business exemption.
That is the same wall the lip care property describes, and it is reached the same way.
Antibacterial specifically
The one soap makers most want to say, and the one with the most history behind it.
An antibacterial claim on a wash product is a drug claim requiring an active that is recognized for that use, and the regulatory history of consumer antibacterial washes is one of ingredients being removed rather than added.
Which means a maker wanting to make that claim has a narrow set of options and a real program of work, not a label change.
The honest position
Almost no handmade soap maker should be in this category.
The claims that get you here are not worth what they cost, and the versions of them that are permitted, describing the ingredients, describing the feel, are available for free.
If a customer asks whether a bar will help their eczema, the honest and compliant answer is that you cannot say, and that describes the situation accurately.