Crotamiton is an anti-parasite medicine that kills certain parasites that live or lay eggs in your skin.

Crotamiton topical (for the skin) is used to treat scabies and to reduce itching associated with certain skin conditions.

Crotamiton topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Crotamiton topical is for use only on the skin. Do not use this medicine on swollen or oozing skin. If this medicine gets in your eyes or mouth, rinse with water.

Shake the lotion well just before each use.

To treat itching:

• Massage the medicine into the affected areas until it is completely absorbed. Repeat as needed.

To treat scabies:

• Take a bath or shower and dry your skin thoroughly before applying this medicine.

• Apply a thin layer of the cream or lotion to all body parts from the neck down to the soles of your feet (scabies does not usually infect the head).

• Be sure the medicine gets into all the folds of your skin, between your toes and fingers, and underneath your nails. Scabies are likely to stay under the nails if the area is not treated. Keep the nails trimmed short.

• Leave the medicine on for 24 hours. Then apply a second dose without washing your skin first.

• Thoroughly wash off the medicine 48 hours after the last application.

Call your doctor if you still have itching 2 to 4 weeks after you finish treatment for scabies.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs with a strong cleanser in hot water to remove any mites or eggs.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Scabies:

Thoroughly massage drug product into the skin of the whole body from the chin to the toes; repeat 24 hours later.

Comments:
-Advise patients to take a cleansing bath 48 hours after the last application.
-A 60 g tube or bottle is sufficient for 2 applications.

Use: For eradication of scabies (Sarcoptes scabiei)

Usual Adult Dose for Pruritus:

Massage drug product gently into affected areas until medication is completely absorbed; repeat as needed.

Use: For symptomatic treatment of pruritic skin

You should not use crotamiton topical if you have ever had an allergic reaction to a topical medication.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether crotamiton topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Crotamiton topical is not approved for use by anyone younger than 18 years old.

You will need to use both doses of crotamiton topical, 24 hours apart. If you miss the second dose, you may need to start your treatment over.

Call your doctor for instructions if you miss a dose.

An overdose of crotamiton topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid getting crotamiton topical in your eyes or mouth.

Parasite infestations are highly contagious. Using this medicine will not prevent you from passing scabies to other people. Avoid sexual or intimate contact until the infestation has cleared up. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, and other articles of personal use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

crotamiton topical may cause serious side effects. Stop using crotamiton topical and call your doctor at once if you have:

• severe burning, stinging, or irritation after using this medicine.

Common side effects of crotamiton topical may include:

• mild itching or new rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.