Pyrethrin and Piperonyl Butoxide Topical

Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.

Pyrethrin and piperonyl butoxide comes as a shampoo to apply to the skin and hair. It is usually applied to the skin and hair in two or three treatments. The second treatment must be applied 7-10 days after the first one. Sometimes a third treatment may be necessary, as recommended by your doctor. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use pyrethrin and piperonyl butoxide shampoo exactly as directed. Do not use more or less of it or use it more often than directed on the package label or prescribed by your doctor.

The package label gives you an estimate of how much shampoo you will need based on your hair length. Be sure to use enough shampoo to cover all of your scalp area and hair.

Pyrethrin and piperonyl butoxide shampoo should only be used on the skin or hair and scalp. Avoid getting pyrethrin and piperonyl butoxide shampoo in your eyes, nose, mouth, or vagina. Do not use it on your eyebrows or eyelashes.

If pyrethrin and piperonyl butoxide shampoo gets in your eyes, flush them with water right away. If your eyes are still irritated after flushing with water, call your doctor or get medical help right away.

To use the shampoo, follow these steps:

1. Shake the shampoo well right before use to mix the medication evenly.
2. Use a towel to cover your face and eyes. Be sure to keep your eyes closed during this treatment. You may need to have an adult help you apply the shampoo.
3. Apply pyrethrin and piperonyl butoxide shampoo to your dry hair and scalp area or skin. If you have head lice, begin to apply the shampoo behind your ears and at the back of your neck and then cover all of the hair on your head and scalp.
4. Keep the shampoo on for 10 minutes, but no longer. You should use a timer or clock to track the time.
5. After 10 minutes, use a small amount of warm water to form a lather and shampoo as usual. Rinse your hair and scalp or skin thoroughly with warm water.
6. If you have head lice, dry your hair with a towel and comb out tangles.
7. A lice comb may also be used to remove the dead lice and nits (empty egg shells) after this treatment. You may also need to have an adult help you to do this.
8. You will need to repeat this entire process in 7-10 days to kill the lice that hatch from eggs.

After using pyrethrin and piperonyl butoxide shampoo, sanitize all the clothing, underwear, pajamas, hats, sheets, pillowcases, and towels you have used recently. These items should be washed in very hot water or dry-cleaned. You should also wash combs, brushes, hairs clips and other personal care items in hot water.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using pyrethrin and piperonyl butoxide shampoo,

• tell your doctor and pharmacist if you are allergic to pyrethrin, piperonyl butoxide, chrysanthemums, ragweed, any other medications, or any of the ingredients in pyrethrin and piperonyl butoxide shampoo. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had skin conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using pyrethrin and piperonyl butoxide shampoo, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

It is important to apply pyrethrin and piperonyl butoxide shampoo again in 7 to 10 days after the first application. If you miss the second treatment, call your doctor to discuss your treatment schedule.

Pyrethrin and piperonyl butoxide shampoo may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching of skin or scalp area
• redness of skin or scalp area

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• trouble breathing
• continued irritation of the skin or scalp area
• infected or pus filled areas of the skin or scalp area

Pyrethrin and piperonyl butoxide shampoo may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

If someone swallows pyrethrin and piperonyl butoxide shampoo, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

If you feel you need additional treatment for lice after completing use of pyrethrin and piperonyl butoxide shampoo, call your doctor.

Ask your pharmacist any questions you have about pyrethrin and piperonyl butoxide shampoo.

Lice are generally spread by close head-to-head contact or from items which come in contact with your head. Do not share combs, brushes, towels, pillows, hats, scarves, or hair accessories. Be sure to check everyone in your immediate family for head lice if another family member is being treated for lice.

If you have pubic lice, your sexual partner should also be treated.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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