Ethyl Butylacetylaminopropionate

Approved Indications:

• Insect Repellent:
  Indicated for topical use to repel mosquitoes, ticks, biting flies, midges, and other biting insects.
• Prevention of Insect-borne Diseases:
  Used to reduce risk of insect bites that may transmit diseases such as malaria, dengue, Lyme disease, and Zika virus.

Off-label / Clinically Accepted Uses:

• Repellent for use in outdoor activities including hiking, camping, and military applications.
• Protection against nuisance insects to prevent allergic reactions or secondary infections.

Route of Administration: Topical application on exposed skin and/or clothing.

Dosage Instructions:

• Apply evenly to exposed skin and clothing avoiding eyes, mouth, and open wounds.
• Use as needed for protection; reapply every 4–8 hours depending on exposure and product formulation.
• Avoid excessive application; use a thin, uniform layer.
• Wash off with soap and water after returning indoors or before sleep.

Special Populations:

• Children:
  Safe for children over 2 months (product-specific), apply sparingly. Avoid hands and face to prevent ingestion or eye contact.
• Pregnant and Lactating Women:
  Use only if necessary; apply minimal effective amount.
• Elderly:
  No dosage adjustment; apply per standard guidelines.
• Renal/Hepatic Impairment:
  Not systemically absorbed; no dose modification needed.

Ethyl Butylacetylaminopropionate acts as an insect repellent by interfering with the insect’s olfactory receptors, masking the human scents and carbon dioxide cues that attract blood-feeding insects. This chemical camouflage reduces insect landing and biting, thereby preventing insect bites without killing the insects. The compound’s low volatility ensures prolonged protection on the skin surface.

• Absorption: Minimal systemic absorption through intact skin.
• Distribution: No systemic distribution due to topical use.
• Metabolism: Not significantly metabolized systemically.
• Elimination: Primarily eliminated by washing off the skin or natural skin shedding.
• Onset: Immediate repellent effect upon application.
• Duration: Protection lasts typically 4–8 hours depending on formulation and environmental conditions.

• Pregnancy:
  No formal FDA pregnancy category assigned. Topical use is considered low risk due to minimal systemic absorption. Recommended only if necessary.
• Lactation:
  Considered safe with minimal systemic exposure. Avoid application on breasts to prevent infant ingestion.

• Primary Class: Topical Insect Repellent
• Subclass: Synthetic repellent agent (non-DEET)

• Known hypersensitivity or allergic reaction to Ethyl Butylacetylaminopropionate or formulation excipients.
• Application on irritated, damaged, or broken skin.
• Avoid contact with eyes, mucous membranes, and lips.

• Avoid ingestion: Toxic if swallowed.
• Eye Contact: May cause irritation; rinse immediately if contact occurs.
• Skin Sensitivity: Rare cases of contact dermatitis reported; discontinue use if rash or irritation develops.
• Flammability: Avoid use near open flames or high heat sources.
• Children: Use sparingly and avoid application on hands or near mouth.
• Do not apply under clothing to avoid prolonged skin exposure and irritation.

Common Adverse Effects:

• Mild skin irritation or redness
• Transient burning or stinging sensation upon application
• Occasional dry skin or itching

Rare Side Effects:

• Allergic contact dermatitis
• Eye irritation on accidental exposure

• No known systemic drug interactions due to minimal absorption.
• Avoid simultaneous use with other topical products that may cause skin irritation.

• WHO endorses Ethyl Butylacetylaminopropionate (IR3535) as a safe and effective alternative to DEET, especially for use in children and sensitive populations.
• Recent guidelines emphasize its use in integrated vector management strategies in malaria-endemic regions.
• Regulatory agencies continue to recommend proper labeling on safe use and reapplication intervals.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from heat, flames, and direct sunlight due to flammable solvent base.
• Keep container tightly closed and out of reach of children.
• Do not freeze; store in a dry place.