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 physcian 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. Slight stinging sensations may occur with the use of OVIDE 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

1. OVIDE 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 OVIDE Lotion should wash hands after application. 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. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.
3. In case of accidental ingestion of OVIDE Lotion by mouth, seek medical attention immediately.
4. If you are pregnant or nursing, you should contact your physician before using OVIDE Lotion.
5. If OVIDE Lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists or if visual changes occur.
6. If skin irritation occurs, wash scalp and hair immediately. If the irritation clears, OVIDE Lotion may be reapplied. If irritation reoccurs, consult a physician.
7. Slight stinging sensations may be produced when using OVIDE Lotion.
8. Apply OVIDE 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 OVIDE Lotion. Anyone applying OVIDE Lotion should wash hands immediately after the application process is complete.
9. 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.
10. Rinse hair and use a fine-toothed (nit) comb to remove dead lice and eggs.
11. If lice are still present after 7-9 days, repeat with a second application of OVIDE Lotion.
12. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Laboratory Tests: There are no special laboratory tests needed in order to use this medication.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Although carcinogenesis, mutagenesis, and impairment of fertility have not been studied with OVIDE Lotion, malathion has been shown to be genotoxic in a number of in vitro and in vivo mutation and clastogenicity assays. However, there was no evidence of a carcinogenic effect following long-term oral administration of malathion in F344 rats after 2 years feeding with up to 0.4% (~ 200 - 400 mg/kg/day) nor was it tumorigenic in Osborne - Mendel rats or B6C3F1 mice after similar feeding for 80 weeks with 0.8% (~ 400 - 600 mg/kg/day) or 1.6% (~ 1,000 -2,000 mg/kg/day), respectively. Based on body surface area, doses tested are approximately 4 to 40 fold greater than those anticipated in humans (assuming 100% bioavailability). Reproduction studies performed with malathion in rats at doses approximately 30 fold greater than those anticipated in humans (based on body surface area and assuming 100% bioavailability) revealed no evidence of impaired fertility.

Pregnancy: Pregnancy Category B. There was no evidence of teratogenicity in studies in rats and rabbits at doses up to 900 mg/kg/day and 100 mg/kg/day malathion, respectively. A study in rats failed to show any gross fetal abnormalities attributable to feeding malathion up to 2,500 ppm (~ 200 mg/kg/day) in the diet during a three-generation evaluation period. These doses were approximately 2 to 10 times higher than the anticipated human dose (based on body surface area and assuming 100% bioavailability). Because animal reproduction studies are not always predictive of human responses, this drug should be used (or handled) during pregnancy only if clearly needed.

Nursing Mothers: Malathion in an acetone vehicle has been reported to be absorbed through human skin to the extent of 8% of the applied dose. However, percutaneous absorption from the OVIDE® (malathion) Lotion, 0.5% formulation has not been studied, and it is not known whether malathion is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OVIDE Lotion is administered to (or handled by) a nursing mother.

Pediatric Use: The safety and effectiveness of OVIDE Lotion in children less than 6 years of age has not been established via well-controlled trials.

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