Malathion .0005 g/mL

Malathion · LOTION · Sun Pharmaceutical Industries, Inc.

No Recall History

Plain English

Malathion lotion is a prescription medication used to treat head lice infestations. It works by inhibiting cholinesterase, an enzyme that lice need to survive, effectively killing the parasites when applied to the scalp and hair.

Key Facts

Brand Name: Malathion
Generic Name: Malathion
NDC Code (Product): 51672-5294
Manufacturer: Sun Pharmaceutical Industries, Inc.
Strength: .0005 g/mL
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: ANDA091559
Drug Class: Cholinesterase Inhibitor [EPC]
Marketing Start: 01/31/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective9 reports

drug exposure during pregnancy7 reports

pain7 reports

pregnancy with injectable contraceptive7 reports

vomiting6 reports

chemical poisoning4 reports

hallucination4 reports

nausea4 reports

alopecia3 reports

anxiety3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Malathion lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply malathion lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying malathion lotion. Wash hands after applying to scalp. Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered. After 8 to 12 hours, the hair should be shampooed. Rinse and use a fine - toothed (nit) comb to remove dead lice and eggs. If lice are still present after 7 - 9 days, repeat with a second application of malathion lotion. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Warnings

WARNINGS Malathion lotion is flammable. The lotion and wet hair should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. Allow hair to dry naturally and to remain uncovered after application of malathion lotion. Malathion lotion should only be used on children under the direct supervision of an adult. If malathion lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists. If skin irritation occurs, discontinue use of product until irritation clears. Reapply the malathion lotion, and if irritation reoccurs, consult a physician. Chemical burns including second-degree burns and stinging sensations may occur with the use of malathion lotion. General Keep out of reach of children. Close eyes tightly during product application. If accidentally placed in the eye, flush immediately with water. Use only on scalp hair. Information to Patients Malathion lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke w…

Contraindications

CONTRAINDICATIONS Malathion lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. Malathion lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.

Adverse Reactions

ADVERSE REACTIONS Malathion has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis. It is not known if malathion lotion has the potential to cause contact allergic sensitization.