Ovide ® (malathion) Lotion, 0.5%

NDC 51672-5293-4

Rx Only

For topical use only. Not for oral or ophthalmic use.

OVIDE 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 C ₁₀H ₁₉O ₆PS ₂, and has the following chemical structure:

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 OVIDE 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.

OVIDE Lotion is indicated for patients infected with Pediculus humanus capitis(head lice and their ova) of the scalp hair.

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

1. OVIDE 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 OVIDE Lotion.
2. OVIDE Lotion should only be used on children under the direct supervision of an adult.
3. If OVIDE Lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists.
4. If skin irritation occurs, discontinue use of product until irritation clears. Reapply the OVIDE Lotion, and if irritation reoccurs, consult a physician.
5. Chemical burns including second-degree burns and stinging sensations may occur with the use of OVIDE Lotion.

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 OVIDE Lotion has the potential to cause contact allergic sensitization.

Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.

Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.

Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion.

Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - range prognosis.

1. Apply OVIDE Lotion on DRYhair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying OVIDE Lotion. Wash hands after applying to scalp.
2. Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered.
3. After 8 to 12 hours, the hair should be shampooed.
4. Rinse and use a fine - toothed (nit) comb to remove dead lice and eggs.
5. If lice are still present after 7 - 9 days, repeat with a second application of OVIDE 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.

Two controlled clinical trials evaluated the pediculicidal activity of OVIDE Lotion. Patients applied the lotion to the hair and scalp in quantities, up to a maximum of 2 fl. oz., sufficient to thoroughly wet the hair and scalp. The lotion was allowed to air dry and was shampooed with Prell shampoo 8 to 12 hours after application. Patients in both the OVIDE Lotion group and in the vehicle group were examined immediately after shampooing, 24 hours after, and 7 days after for the presence of live lice. Results are shown in the following table:

The presence or absence of ova at day 7 was not evaluated in these studies. The presence or absence of live lice or ova at 14 days following treatment was not evaluated in these studies. The residual amount of malathion on hair and scalp is unknown.

OVIDE ^®(malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5293-4.

Manufactured for:
TaroPharma ^®
a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Manufactured By: Suven Life Sciences Limited, Plot No. 262-271, IDA, Pashamylaram, Sangareddy District,
Telangana, 502307 India.

Ovide ^®and TaroPharma ^®are trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Lb30005-4-02
Issued: March, 2017
0317-2

NDC 51672-5293-4

OVIDE ^®
(malathion)
LOTION, 0.5%

In isopropyl alcohol (78%),
terpineol, dipentene and
pine needle oil.

PEDICULICIDE/OVICIDE

WARNING:
Contains flammable alcohol.
Avoid smoking, open flame and hair dryers.
Allow hair to dry naturally and uncovered.

Rx Only

Taro Pharma ^®

2 fl. oz. (59 mL)