FDA Issues Emergency Use Authorization for F10 Antiseptic Barrier Ointment for New World Screwworm
Summary
The FDA issued an Emergency Use Authorization (EUA) on April 24, 2026, for F10 Antiseptic Barrier Ointment with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical ointment) to prevent and treat New World screwworm infestations in cattle, horses, sheep, goats, deer, wild birds, pet birds, and captive wild, exotic, and zoo mammals. The product may not be used in domestic dogs and cats. Food safety requirements include a 30-day slaughter withdrawal period for cattle, goats, and sheep, and a 10-day milk discard time. The EUA remains effective until revoked or the HHS Secretary terminates the NWS public health emergency declaration. The product is sponsored by Health and Hygiene (Pty) Ltd of South Africa and is available over the counter.
“The FDA has concluded that based on the scientific evidence available, it is reasonable to believe that F10 Antiseptic Barrier Ointment 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.”
Livestock producers and animal health practitioners using F10 Antiseptic Barrier Ointment under this EUA must enforce the 30-day slaughter withdrawal for cattle, goats, and sheep and the 10-day milk discard period for dairy animals. Producers of veal from calves born to treated cows face a complete prohibition on processing for human consumption. Zoos, wildlife rehabilitators, and horse facilities treating exotic or wild species should document all treatments to demonstrate compliance with the EUA terms if audited.
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What changed
The FDA issued an Emergency Use Authorization for F10 Antiseptic Barrier Ointment with Insecticide, a previously unapproved animal drug now authorized for emergency use against New World screwworm infestations in multiple species including cattle, horses, small hoofstock, birds, and captive exotic mammals. The product may not be used in domestic dogs and cats. Food safety requirements apply: treated cattle, goats, and sheep cannot be slaughtered within 30 days of treatment, and milk from treated dairy animals cannot be used for human consumption within 10 days after treatment.
Affected parties include livestock producers, zoo operators, wildlife rehabilitators, horse owners, and pet bird owners who may now access this OTC product for screwworm prevention and treatment. Compliance with the labeled withdrawal periods and milk discard times is required when following the EUA terms. Pre-ruminating calves cannot be processed for veal if born to treated cows.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
April 24, 2026
Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for F10 Antiseptic Barrier Ointment with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical ointment) 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 Barrier Ointment 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 Barrier Ointment with Insecticide may not be used in domestic dogs and cats.
Prior to this ointment formulation, the FDA authorized F10 Antiseptic Wound Spray with Insecticide on March 10, 2026.
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 can be found in the Fact Sheet: Emergency Use Authorization of F10 Antiseptic Barrier Ointment with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical ointment) for New World Screwworm (NWS).
F10 Antiseptic Barrier Ointment with Insecticide is available over the counter without a prescription. The FDA added F10 Antiseptic Barrier Ointment with Insecticide (Minor Species Index File (MIF) 900-011) 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 to 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 Barrier Ointment with Insecticide is sponsored by Health and Hygiene (Pty) Ltd, based in South Africa.
Additional Information
- Freedom of Information Summary: F10 Antiseptic Barrier Ointment with Insecticide (EUA 006677)
- Letter of Authorization: F10 Antiseptic Barrier Ointment with Insecticide (EUA 006677)
- Fact Sheet: Emergency Use Authorization of F10 Antiseptic Barrier Ointment with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical ointment) for New World Screwworm (NWS)
- Animal Drugs for New World Screwworm
Content current as of:
04/24/2026
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