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.

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

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

CONTRAINDICATIONS

Not to be used by patients allergic to ingredients.

PRECAUTIONS

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

Information for Patients:   See 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.

ADVERSE REACTIONS

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.

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

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).

HOW SUPPLIED

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

(.2960)

December, 1998