FDA Issues Emergency Use Authorization for F10 Antiseptic Wound Spray for New World Screwworm
Summary
The FDA has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide for the prevention and treatment of New World screwworm in multiple animal species, excluding domestic dogs and cats. This authorization allows for broader use than previously approved products, with specific food safety guidelines for treated animals.
What changed
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide. This authorization permits the prevention and treatment of New World screwworm (NWS) infestations in cattle, sheep, goats, horses, wild and exotic mammals, and wild and pet birds. Notably, this product is not approved for use in domestic dogs and cats. The FDA determined that the product's potential benefits outweigh its risks for these specified species, and has also established food safety guidelines, including withdrawal periods for meat and milk from treated animals.
Regulated entities, particularly manufacturers and veterinarians involved with the specified livestock and animal populations, should familiarize themselves with the terms and conditions of the EUA. This includes adhering to the stated withdrawal periods for meat and milk to ensure food safety. While the product is available over-the-counter, compliance with the EUA's specific use instructions is critical. The EUA remains in effect until terminated by the HHS Secretary or revoked by the FDA, tied to the ongoing declaration of a public health emergency for NWS.
What to do next
- Review FDA's Emergency Use Authorization for F10 Antiseptic Wound Spray with Insecticide.
- Ensure adherence to specified withdrawal periods for meat and milk from treated cattle, goats, and sheep.
- Verify product use is limited to approved species and does not include domestic dogs and cats.
Source document (simplified)
March 10, 2026
Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide (benzalkonium chloride, polyhexanide, and cypermethrin topical solution) for the prevention and treatment of New World screwworm (NWS) infestations (myiasis).
The FDA has concluded that based on the scientific evidence available, it is reasonable to believe that F10 Antiseptic Wound Spray with Insecticide may be effective in the prevention and treatment of NWS myiasis in cattle, horses, minor species of hoof stock (e.g., sheep, goats, deer), raptors and other wild birds, pet birds, and captive wild, exotic, and zoo mammals, and the known and potential benefits of the product outweigh its known and potential risks. F10 Antiseptic Wound Spray with Insecticide may not be used in domestic dogs and cats.
Most animals in America are at low risk of NWS due to their geographic location; however, animals near the U.S.-Mexico border and those that have been in countries with active NWS cases are more likely to be exposed to NWS.
To date, the FDA has conditionally approved or issued EUAs for drugs to prevent and/or treat NWS in cattle, dogs, and cats. F10 Antiseptic Wound Spray with Insecticide is the first product authorized by the FDA for NWS indications in additional species.
The agency evaluated relevant human food safety information and concluded that the food products obtained from treated animals are safe for human consumption when the terms and conditions of use granted by the EUA are followed, including the withdrawal period and milk discard time.
Important food safety information:
- Cattle, goats, and sheep must not be slaughtered for human consumption within 30 days of treatment.
- For non-domesticated minor species of hoof stock (e.g., deer, elk, antelope and nilgai), use only when there is a reasonable certainty that the treated animal will not be slaughtered or harvested for human consumption within 30 days of treatment.
- Milk taken from cows, goats, or sheep during treatment and for 10 days after treatment must not be used for human consumption.
- A withdrawal period has not been established for this product in pre-ruminating calves. Treated calves and calves born to treated cows must not be processed for veal. Detailed product information about F10 Antiseptic Wound Spray with Insecticide can be found in the Fact Sheet: Emergency Use Authorization of F10 Antiseptic Wound Spray with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical solution) for New World Screwworm (NWS).
F10 Antiseptic Wound Spray with Insecticide is available over the counter without a prescription. The FDA added the F10 Antiseptic Wound Spray with Insecticide (Minor Species Index File [MIF] 900-010) to The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species in 2015 for use as a topical antiseptic for surface wounds, to repel flies and treat infestations due to fly strike in raptors, pet birds, captive small mammals, captive reptiles and captive exotic/zoo mammals. The product has not been through the FDA’s approval or conditional approval process.
This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.
F10 Antiseptic Wound Spray with Insecticide is sponsored by Health and Hygiene (Pty) Ltd, based in South Africa.
Additional Information
- Freedom of Information Summary: F10 Antiseptic Wound Spray with Insecticide (EUA 006672)
- Letter of Authorization: F10 Antiseptic Wound Spray with Insecticide (EUA 006672)
- Fact Sheet: Emergency Use Authorization of F10 Antiseptic Wound Spray with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical solution) for New World Screwworm (NWS)
- Animal Drugs for New World Screwworm
Content current as of:
03/10/2026
Regulated Product(s)
- Animal & Veterinary
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