Dermax Co., Ltd
FDA issued a warning letter to Dermax Co., Ltd. (operating dermaxshop.com, based in China) for selling unapproved and misbranded injectable botulinum toxin products — specifically 'Botulax 100U' — to U.S. consumers without an approved NDA under FD&C Act section 505. The products were marketed with claims such as 'reducing sweating' for underarms, palms, and feet, constituting drug-intended use without FDA approval. FDA demands cessation of sales to U.S. consumers, a written corrective action response within 15 working days, and warns that failure to comply may result in seizure or injunction.
Flagged claims (1)
reducing sweating. Underarms, palms, and feet are subject to increased sweating.
Required actions (3)
FDA requests that www.dermaxshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice.
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