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

1. Apply OVIDE 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 OVIDE Lotion. Wash hands after applying to scalp.

2. Allow hair to dry naturallyuse 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.

Clinical Studies: 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 99207- 650 - 02. Store at controlled room temperature 20° - 25°C (68° - 77°F).

Manufactured for: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 by DTP Lakewood, Inc. Lakewood, NJ 08701, Ovide is a registerd trademark of Genderm Corporation, used under license by Taro Pharmaceuticals U.S.A., Inc., © 2003 Taro Pharmaceuticals U.S.A., Inc.

Updated Nov 25, 2003

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