SELSUN®, a liquid antiseborrheic, antifungal preparation for topical application. Contains: Selenium sulfide 2 ¹ [sol ] ₂ % w/v in aqueous suspension; also contains: bentonite, lauric diethanolamide, ethylene glycol monostearate, titanium dioxide, amphoteric-2, sodium lauryl sulfate, sodium phosphate (monobasic), glyceryl monoricinoleate, citric acid, captan and perfume.

Treatment of tinea versicolor, seborrheic dermatitis of scalp and treatment of dandruff.

See application instructions.

Treatment of tinea versicolor:   Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for 7 days.

Treatment of seborrheic dermatitis and dandruff:   Usually two applications each week for two weeks will afford control. After this, may be used at less frequent intervals weekly, every two weeks, or every 3 or 4 weeks in some cases. Should not be applied more frequently than required to maintain control.

APPLICATION INSTRUCTIONS:   Keep tightly capped.

Shake well before using. Product may damage jewelry; remove jewelry before use.

For treatment of tinea versicolor:

1. Apply to affected areas and lather with a small amount of water.
2. Allow to remain on skin for 10 minutes.
3. Rinse body thoroughly.
4. Repeat this procedure once a day for 7 days.

For treatment of dandruff and seborrheic dermatitis of the scalp:

1. Massage about 1 or 2 teaspoonfuls of shampoo into wet scalp.
2. Allow to remain on scalp for 2 to 3 minutes.
3. Rinse scalp thoroughly.
4. Repeat application and rinse thoroughly.
5. After treatment, wash hands well.
6. Repeat treatments as directed by physician.

WARNINGS AND PRECAUTIONS:

For External Use Only. Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area and skin folds as it may cause irritation and burning. These areas should be thoroughly rinsed after application. Keep this and all medicines out of reach of children.

Store below 86°F (30°C).

4-fl-oz bottles (NDC 0074-2660-04).

In decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

No Information Provided.

No Information Provided.

General: Not to be used when inflammation or exudation is present as increased absorption may occur.

Information for Patients:   See Warnings and Precautions section under Application Instructions.

Carcinogenesis:   Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.

Pregnancy:   WHEN USED FOR THE TREATMENT OF TINEA VERSICOLOR, SELSUN IS CLASSIFIED AS PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with SELSUN. It is also not known whether SELSUN can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances SELSUN should not be used for the treatment of tinea versicolor in pregnant women.

Pediatric Use:   Safety and effectiveness in infants have not been established.

Accidental Oral Ingestion:

No documented reports of serious toxicity in humans resulting from acute ingestion of SELSUN, however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.

Not to be used by patients allergic to ingredients.

Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.

See Warnings and Precautions section under Application Instructions.

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.

SELENIUM SULFIDE - TOPICAL

(seh-LEE-nee-um SUL-fide)

COMMON BRAND NAME(S): Dandrex, Exsel, Selsun Blue

USES: This medication is used to treat dandruff and a certain scalp infection (seborrheic dermatitis). It reduces itching, flaking, irritation, and redness of the scalp. Selenium sulfide is also used for a condition that causes discoloration of the skin (tinea versicolor). This medication belongs to a class of medications called anti-infectives. It works by slowing the growth of the yeast that causes the infection.

HOW TO USE: This medication is for use on the skin only. Shake the bottle well before use. Before using this medication, remove any jewelry to avoid damage to it. Avoid getting this medication near your eyes. If any medication gets in your eyes, rinse thoroughly with water. Do not use this medication on damaged, cut, inflamed, or irritated skin (e.g., open sores). Consult your doctor or pharmacist if you have any questions about how to use this medication properly.

For the treatment of dandruff or scalp dermatitis, follow the manufacturer's instructions, or use as directed by your doctor. Wet the scalp and massage the medication onto the wet scalp. Leave it on your scalp for 2-3 minutes. Rinse thoroughly and repeat the application. Be sure to rinse your hair and scalp well with water after each application, especially on bleached, tinted, or permed hair. This medication is usually used 1 or 2 times per week to treat dandruff or seborrheic dermatitis, or less frequently to maintain control of dandruff.

For the treatment of tinea versicolor, apply selenium sulfide to the affected skin. Lather with a small amount of water. Allow it to remain on your skin for 10 minutes. Rinse your skin thoroughly with water after each use. If the medication touches the genital areas or skin folds, rinse the area well with water for a few minutes to prevent irritation. This medication is applied usually once daily for 7 days to treat tinea versicolor, or use as directed by your doctor.

Wash your hands after using selenium sulfide. Do not leave this medication on your hair, scalp, or skin for a longer period or use it more often than directed. Your condition will not clear faster, but side effects may be increased.

If your condition worsens or does not improve, tell your doctor or pharmacist promptly.

SIDE EFFECTS: Skin irritation, dry skin, oily or dry hair/scalp, or temporary hair loss may occur. If any of these effects persist or worsen, discontinue use and consult your doctor or pharmacist promptly. Hair discoloration may occur and can be reduced by carefully rinsing the hair thoroughly after each treatment.

If your doctor has prescribed this medication, remember that 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: 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 selenium sulfide, 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: red/irritated/broken skin.

This medication is not recommended for children younger than 2 years. Consult your doctor before using this medication.

If you are using selenium sulfide on the body for tinea versicolor, this medication should be used during pregnancy only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Though there have been no reports of harm to nursing infants, 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 overdose or swallowing 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.

NOTES: Keep all medical and laboratory appointments.

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). Keep the container tightly closed. Avoid freezing. Keep all medications 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.