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Is CHG approved as a safe drug?

The FDA’s TFM entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products” lists those active ingredients which the FDA recognizes as “generally safe and effective” (Category I) for preparation of the skin prior to surgery.  They are:

• Ethyl alcohol or ethanol (EtOH; CH3CH2OH) 60% to 95%
• Isopropyl alcohol or 2-propanol (IPA; CH3CHOHCH3) 70% to 91%
• Iodine topical solution U.S.P. (aqueous)
• Iodine tincture U.S.P.; essentially Iodine Topical Solution, USP where half of the water has been replaced with ethyl alcohol
• Povidone-iodine (PVP-Iodine; PVP-I) 5% to 10%

Because formulations containing Category I ingredients are recognized by the FDA as “generally safe and effective”, no agency approval is required prior to marketing.  Formulations indicated for preparation of the skin prior to surgery containing active ingredients other than those listed above as Category I (e.g., CHG) can only be marketed in the United States after receiving approval from the FDA through the New Drug or Abbreviated New Drug Application (NDA, ANDA) process.

Thus, products containing CHG that have been approved by the FDA are safe for their labeled use(s).

Click here for a copy of the TFM.

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