Label: SELENIUM SULFIDE lotion

  • NDC Code(s): 60432-528-04, 60432-528-05
  • Packager: Morton Grove Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 16, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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 SULFIDE LOTION, USP 2.5% IS CLASSIFIED AS PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with selenium sulfide.  It is also not known whether selenium sulfide can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity.  Under ordinary circumstances selenium sulfide 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 selenium sulfide, 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
  • For 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 the body thoroughly. Repeat procedure once a day for 7 days.

  • For treatment of dandruff and seborrheic dermatitis

    Usually two applications each week for two weeks will afford control. After this, the lotion 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.

  • HOW SUPPLIED

    Selenium Sulfide Lotion, USP 2.5% is supplied in 4 fl oz (118 mL) bottles.

    PROTECT FROM HEAT. FOR EXTERNAL USE ONLY.

  • WARNINGS

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Rx Only

    Product No.: 8528

    A50-8528-04

    REV. 01-05

    Manufactured By:

    Morton Grove Pharmaceuticals, Inc.

    Morton Grove, IL 60053

  • PRINCIPAL DISPLAY PANEL Bottle Label

    MGP

    NDC 60432-528-04

    6506-00-299-8671

    SELENIUM SULFIDE

    LOTION, USP 2.5%

    DESCRIPTION: Selenium Sulfide Lotion, USP 2.5% is a

    liquid antiseborrheic, antifungal preparation for topical

     application, containing selenium sulfide 2.5% w/v in

    aqueous suspension. Also contains: Amphoteric-2;

    Bentonite, NF; Captan; Citric Acid, USP; D&C Yellow

    #10; Ethylene Glycol Monostearate; Glyceryl

    Monoricinoleate; Lauric Diethanolamide; Perfume;

    Purified Water, USP; Sodium Lauryl Sulfate; Sodium

    Phosphate Monobasic, USP and Titanium Dioxide, USP.

    Additional prescribing information inside.

    WARNING: KEEP OUT OF THE REACH OF CHILDREN.

    FOR EXTERNAL USE ONLY.

    Store at controlled room temperature, (15 - 30) °C

    ((59 -  86) °F) [see USP].

    Rx Only

    NET: 4 fl oz (118 mL)

    Manufactured By:

    Morton Grove

    Pharmaceuticals, Inc.

    Morton Grove, IL 60053

    DO NOT USE IF INNER FOIL

    SEAL PRINTED "SEALED

    FOR YOUR PROTECTION"

     IS BROKEN OR MISSING.

    selenium-01

    MGP

    NDC 60432-528-05

    Selenium Sulfide Lotion, USP 2.5%

    FOR EXTERNAL USE ONLY

    Rx Only

    Net: 4 fl oz (118 mL)

    Selenium Sulfide Lotion, USP 2.5% Carton

    Selenium Sulfide Lotion, USP 2.5% Carton

  • INGREDIENTS AND APPEARANCE
    SELENIUM SULFIDE 
    selenium sulfide lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60432-528
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    CAPTAN (UNII: EOL5G26Q9F)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERYL RICINOLEATE (UNII: ZUE0CEL42O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60432-528-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/1983
    2NDC:60432-528-051 in 1 CARTON01/16/2019
    2NDC:60432-528-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08822809/01/1983
    Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)
    Registrant - Morton Grove Pharmaceuticals, Inc. (801897505)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morton Grove Pharmaceuticals, Inc.801897505ANALYSIS(60432-528) , MANUFACTURE(60432-528) , PACK(60432-528)