Regulatory Classification of Chloroxylenol (PCMX) in Shampoo for Antiseptic Use
ถามโดย: ไม่ระบุชื่อ
เมื่อ: September 16, 2025
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คำถาม
When using Chloroxylenol (PCMX) (15% Water Soluble) as an ingredient in shampoo for its germ-killing properties, how will the product be classified?
- Will it be considered a registered drug?
- Or will it be classified as a cleaning product that does not require registration?
What are the recommendations regarding this classification?
คำตอบ
When using Chloroxylenol (PCMX) (15% Water Soluble) in shampoo:
- As a cosmetic preservative: If the primary purpose is to act as a preservative in a cosmetic formulation like shampoo, the FDA allows a maximum concentration of 3.33% of Chloroxylenol (15% Water Soluble). In this scenario, the product would be considered a cosmetic.
- For antiseptic/sterilization (killing germs): If you intend to use it at a higher rate than 3.33% or if the main purpose is for its antiseptic or sterilization properties (to kill germs), the product would then be classified as a cleaning product or disinfectant. These types of products typically have different regulatory requirements than cosmetics.
Recommendation: If your goal is to use Chloroxylenol for its germ-killing properties in shampoo, it would likely fall under the category of a cleaning or disinfectant product. You should consult the relevant regulations for cleaning/disinfectant products to ensure compliance, as these may differ from cosmetic regulations.
ผลิตภัณฑ์ที่เกี่ยวข้องที่กล่าวถึง
Chloroxylenol (PCMX) (15% Water Soluble)
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