Delivery Method: Via Email Product: Drugs
Over-the-Counter Drugs Issuing Office: Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

November 13, 2025

RE: 717838

Save Rite Medical:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.saveritemedical.com. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter “Ameriderm Ameriwash Antimicrobial Lotion Soaps with Triclosan”) for sale in United States. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug and Misbranded Drug Violations

“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.

Examples from the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, www.saveritemedical.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:

“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan”

“Antimicrobial…soap with Triclosan…made especially for the healthcare industry…for use in hospitals and nursing homes. •Kills bacteria on contact….” [from your website https://www.saveritemedical.com/products/ameriwash-antimicrobial-lotion-soap-with-triclosan-1000-ml]

Based on the above labeling evidence, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.

With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products formulated with triclosan as an active ingredient are not GRASE under a final determination issued under 21 CFR part 330.1

Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov, please include your firm name and the unique identifier “717838” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

_________________

1 On September 6, 2017, FDA issued a final rule establishing that certain ingredients for OTC topical consumer antiseptic wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (81 FR 61106). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(iii). On December 20, 2018, FDA issued a final rule establishing that certain ingredients for OTC health care antiseptic hand wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (82 FR 60474). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(vi). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC 000007, available at OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/).

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