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 C₁₀H₁₉O₆PS₂, and has the following chemical structure:

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 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.

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).

Flammable. Keep away from heat and open flame.

Manufactured for: MEDICIS, The Dermatology Company® by: DPT Lakewood, Lakewood, NJ 08701. FDA Rev date: 4/4/2003

Malathion has been shown to be irritating to the skin and scalp. 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.

No information provided.

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. 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.

Laboratory Tests

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

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis, mutagenesis, and impairment of fertility have not been studied with OVIDE Lotion (0.5% pharmaceutical grade malathion). However, following long-term oral administration of technical grade malathion to rodents via dietary supplementation, increase incidences of hepatocellular neoplastic lesions were observed in B6C3F1 mice dosed for 18 months at malathion doses greater than 1500 mg/kg/day, and in female F344 rats dosed for 2 years at malathion doses greater than 400 mg/kg/day. These tumors occurred only in association with severe hepatic toxicity and chronic suppression acethylcholinesterase activity, or at does causing excessive mortality. Based on body surface area, doses at which carcinogenic effects were observed in rodents following life-time exposures to malathion were approximately 14-to 26-fold greater than the maximum dose anticipated in a 10 kg child following a single use of OVIDE Lotion, assuming 100% bioavailabilty. Actual systemic exposures are expected to be less than 10% of the administered dose.

The malathion of greater than pharmaceutical-grade purity used in OVIDE Lotion has not been tested for genotoxicity. The technical-grade malathion (95% pure) was found to be negative in Salmonella typhimurium, equivocally positive in the mouse lymphoma cell assay, and positive in in vitro chromosomal aberration and sister chromatid exchange assays. Fifteen separate in vitro mutation studies with malathion of unknown purity have reported negative results, while three studies reported malathion to be mutagenic in bacterial cells. Both technical grade (94-96,5%) and purified (98-99%) malathion have been reported to cause chromosomal aberrations and sister chromatid exchanges in vitro in human and hamster cell lines. In vivo chromosomal aberration and micronucleus studies of technical-grade malathion are reported to be positive, whereas an in vivo chromosomal aberration study of >99% pure malathion was reported to be negative. Furthermore, mice exposed to malathion in their drinking water for 7 weeks demonstrated no evidence of chromosome damage in bone marrow cells, spermatogonia, or primary spermatocytes. Lack of details makes independent evaluation of the results of these assays impossible. Ashby and Purchase have suggested that impurities may be responsible for some of the observed genetic activity of malathion.

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.

No information provided.

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.

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.

Malathion is an organophosphate agent which acts as a pediculocide 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.

Clinical Studies

Two controlled clinical trials evaluated the pediculocidal 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:

Number of Patients Without Live Scalp Lice

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.

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.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

MALATHION - TOPICAL

(mal-uh-THIGH-on)

COMMON BRAND NAME(S): Ovide

USES: This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Malathion belongs to a class of drugs known as organophosphates. It works by paralyzing and killing lice and their eggs (nits).

HOW TO USE: Learn all preparation and usage instructions in the product package. If you have any questions, ask your doctor or pharmacist.

This medication is for use on hair and scalp only. Do not swallow. Be careful to avoid getting malathion in your nose, ears, mouth, vagina, or eyes. Protect eyes during application by keeping them tightly closed and covered with a cloth or towel. If the medication accidentally comes in contact with your eyes, flush them with water to reduce irritation. If irritation continues or you experience vision changes, talk to your doctor.

Apply this medication onto dry hair and scalp. Use enough medication to make the hair and scalp wet, especially the back of the head and neck. Allow the hair to air-dry, uncovered. Wash hands after applying this medication. Leave malathion on the hair and scalp for 8-12 hours. Then shampoo and rinse well, especially the back of the head and neck.

Run a fine-toothed comb (nit comb) through your wet hair to remove the dead lice and lice eggs. The infected person should be checked by another person for lice and nits. Please see the instructions in the product package for more details about nit removal. Consult your doctor if lice are still present after 7-9 days. Repeat treatment with this or other medication may be necessary.

This medication may cause a slight stinging feeling on the scalp. This is normal. However, if skin irritation occurs, wash the scalp and hair immediately, allow the irritation to clear, and try using the medication again. If the irritation returns, consult your doctor.

This medication contains an ingredient that could easily catch fire (flammable). Avoid smoking, being around open flames (e.g., fireplaces, stoves, campfires), or electric heat sources such as heaters, hair dryers, and curlers/hair irons while using malathion.

Do not use malathion on newborns or infants.

SIDE EFFECTS: Burning, stinging, dry hair, or a temporary increase in dandruff may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using malathion, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, skin infections, skin or scalp problems (e.g., psoriasis, eczema), open sores/wounds on the scalp (e.g., minor cuts, scrapes).

Constant or forceful scratching of the scalp may lead to a bacterial skin infection. Tell your doctor immediately if you develop worsening redness or pus.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you are pregnant and applying this medication on another person, handle it with care.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: breathing problems, muscle weakness/paralysis, shaking, increased sweating/saliva/tears, increased urine, nausea, vomiting, diarrhea, anxiety, headache, confusion, dizziness, drowsiness, slow or fast heartbeat.

NOTES: Do not share this medication unless directed to do so by your doctor.

One application is usually all that is needed. To avoid giving lice to another person or getting them again, all headwear, scarves, coats, and bed linens should be machine-washed with hot water and dried in a dryer (at high setting) for at least 20 minutes, dry cleaned, sealed in a plastic bag for 2 weeks, or sprayed with a disinfectant that kills lice. Brushes and combs should be soaked in hot water (hotter than 130 degrees F/54 degrees C) for 10 minutes, soaked in alcohol for 1 hour, or thrown away. Furniture and floors should be thoroughly vacuumed.

People who are in close contact with the infected person, such as members of the same household, should also be checked for lice and nits. Treatment may be considered to prevent infestation even if live lice are not found on them.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light, moisture, and open flame. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.