What happened
Original notice title
McDaniel Water, LLC MARCS-CMS 616186, September 07, 2021
From the archived source record
Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.mcdanielwater.com and has observed that you take orders there for the product “Black Indian Salve,” which you also refer to on your website as “Indian Herb,” “X,” and “Black Salve.” As explained further below, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 301(d). Your “Black Indian Salve” is concerning from a public health perspective because it is labeled to contain the ingredients bloodroot (Sanguinaria canadensis) and zinc chloride. On May 16, 2019, the FDA issued a warning letter to McDaniel Life-Line LLC which offered a similar product, “Indian Herb,” for sale directly to consumers. The agency advises you that on February 8, 2019, “Indian Herb” was the subject of a voluntary worldwide recall of all lots of the product that were within expiration. In addition, the FDA Center for Drug Evaluation and Research (CDER) issued a safety alert on February 12, 2019 concerning the potential safety hazard associated with “Indian Herb” (see Indian Herb FDA Alert). Unapproved New Drug Violations You market “Black Indian Salve” as a dietary supplement with directions for both topical application and for ingestion. The ‘Black Indian Salve’ is tracing out the infected area and drawing the poison back into the nucleus. It acts as an anti-oxidant and suppresses the genotoxicity of chemicals. Genotoxic substances are known to be potentially mutagenic or potentially cancerous.” Your “Black Indian Salve” product is also a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 3f63b8e539a5
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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