Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: water, petrolatum, propylene glycol, steareth-2, cetyl alcohol, dimethicone, laureth-23, fragrance, magnesium aluminum silicate, carbomer-934, sodium hydroxide, diazolidinylurea, methylchloroisothiazolinone, methylisothiazolinone and magnesium nitrate. In addition, the cream contains glyceryl stearate. Crotamiton is N-ethyl-N-(o-methylphenyl) -2-butenamide and its structural formula is:

Crotamiton USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28.

For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.

In Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.

In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.

LOTION: Shake well before using.

DIRECTIONS FOR PATIENTS WITH SCABIES:

1. Take a routine bath or shower. Thoroughly massage Eurax cream or lotion into the skin from the chin to the toes including folds and creases.
2. Put Eurax cream or lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Eurax cream or lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
3. A second application is advisable 24 hours later.
4. This 60 gram tube or bottle is sufficient for two applications.
5. Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the washing machine.
6. A cleansing bath should be taken 48 hours after the last application.

Eurax (crotamiton USP)

Cream: 60g tubes (NDC 0072-2103-60; NSN 6505-00-116-0200).

Lotion: 60g (2 oz.) bottles (NDC 0072-2203-60, NSN 6505-01-153- 4423).
454g (16 oz.) bottles (NDC 0072-2203-16).

SHAKE WELL before using.

Store at room temperature.

Keep out of reach of children.

Westwood-Squibb Pharmaceuticals, Inc. A Bristol-Myers Squibb Company, Princeton, NJ 08543, USA. FDA Rev date: 6/26/2003

Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.

None known.

If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.

General

Eurax should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals have not been conducted.

Pregnancy (Category C)

Animal reproduction studies have not been conducted with Eurax. It is also not known whether Eurax can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies with Eurax (crotamiton USP) Lotion/Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed.

Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain.

If accidental ingestion occurs, call your Poison Control Center.

Eurax should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.

Eurax has scabicidal and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.

See DIRECTIONS FOR PATIENTS WITH SCABIES.

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.

CROTAMITON - TOPICAL

(crow-TAM-it-un)

COMMON BRAND NAME(S): Eurax

USES: This medication is used on the skin to relieve itchy skin and to treat scabies (a condition caused by mites living in the skin). Crotamiton belongs to a class of drugs known as antipruritics, which work by soothing irritated skin.

This drug also kills the mites that cause scabies.

HOW TO USE: This medication is for use on the skin only. Do not take this medication by mouth. Avoid the face, eyes, mouth, vagina, and any skin areas that are inflamed, raw, or oozing fluid.

Shake the lotion before use.

To treat scabies, take a bath or shower before using this medication. Remove scaly or crusted skin by rubbing gently. Dry with a towel. Massage a thin layer of the cream or lotion into all skin areas from the chin to the toes, including skin folds and soles of the feet. Trim fingernails and apply the medication under the nails. Apply again after 24 hours. Take a bath 48 hours after the last application to remove the medication from your skin. Tell your doctor if your condition persists or worsens after 3 days.

Change clothing, towels, and bed sheets the next morning after each treatment. Wash all clothing, towels, and bedding in hot water and dry in a hot drier (or dry-clean) to kill all the mites and prevent them from returning.

To treat other skin conditions, massage this product gently into affected areas until the product disappears. Repeat as directed by your doctor.

SIDE EFFECTS: Worsening skin irritation (e.g., burning, redness) 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 crotamiton, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

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 medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your 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. If this product is swallowed, symptoms of overdose may include: irritation/burning feeling in the mouth, persistent nausea/vomiting, stomach/abdominal pain.

NOTES: Do not share this medication with others. If you are being treated for scabies, discuss with your doctor if people with whom you come in close contact (e.g., household members, family, sexual partners) should also be examined and treated for scabies.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. 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.