MALATHION- malathion lotion
Taro Pharmaceuticals U.S.A., Inc.
Rx Only
For topical use only. Not for oral or ophthalmic use.
DESCRIPTION
Malathion lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, dipentene, and pine needle oil. The chemical name of malathion is (�) � [(dimethoxyphosphinothioyl) -- thio] butanedioic acid diethyl ester. Malathion has a molecular weight of 330.36, represented by C10 H19 O6 PS2 Malathion is an organophosphate agent which acts as a pediculicide by inhibiting cholinesterase activity in vivo. Inadvertent transdermal absorption of malathion has occurred from its agricultural use. In such cases, acute toxicity was manifested by excessive cholinergic activity, i.e., increased sweating, salivary and gastric secretion, gastrointestinal and uterine motility, and bradycardia (see OVERDOSAGE). Because the potential for transdermal absorption of malathion from malathion lotion is not known at this time, strict adherence to the dosing instructions regarding its use in children, method of application, duration of exposure, and frequency of application is required.
INDICATIONS AND USAGE
Malathion lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.
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.
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 while applying lotion or while hair is wet.
The person applying malathion lotion should wash hands after application. 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. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.
In case of accidental ingestion of malathion lotion by mouth, seek medical attention immediately.
If you are pregnant or nursing, you should contact your physician before using malathion lotion.
If malathion lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists or if visual changes occur.
If skin irritation occurs, wash scalp and hair immediately. If the irritation clears, malathion lotion may be reapplied. If irritation reoccurs, consult a physician.
Burns and stinging sensations may occur when using malathion lotion.
Apply malathion lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp. Pay particular attention to the back of the head and neck when applying malathion lotion. Anyone applying malathion lotion should wash hands immediately after the application process is complete.
Allow hair to dry naturally and to remain uncovered. Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing.
Rinse hair 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.