SELENIUM SULFIDE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)

Available from:

Morton Grove Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For treatment of tinea versicolor, seborrheic dermatitis of scalp and treatment of dandruff. Not to be used by patients allergic to any of its ingredients.

Product summary:

Selenium Sulfide Lotion, USP 2.5% is supplied in 4 fl oz (118 mL) bottles. PROTECT FROM HEAT. FOR EXTERNAL USE ONLY.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELENIUM SULFIDE- SELENIUM SULFIDE LOTION
MORTON GROVE PHARMACEUTICALS, INC.
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SELENIUM SULFIDE LOTION, USP 2.5%
SHAKE WELL BEFORE USING.
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 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 as it may cause irritation
and burning.
FOR EXTERNAL USE ONLY. WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF
THE REACH OF CHILDREN.
STORE AT CONTROLLED ROOM TEMPERATURE, (15 - 30) °C ((59 - 86) °F)
[SEE USP].
CLINICAL PHARMACOLOGY
Selenium sulfide appears to have a cytostatic effect on cells of the
epidermis and follicular epithelium,
reducing corneocyte production.
INDICATIONS AND USAGE
For treatment of tinea versicolor, seborrheic dermatitis of scalp and
treatment of dandruff.
CONTRAINDICATIONS
Not to be used by patients allergic to any of its ingredients.
PRECAUTIONS
General:
Not to be used when acute 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 ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR,
SELENIUM S