Label: HEB DANDRUFF- selenium sulfide shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 5, 2011

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  • ACTIVE INGREDIENT

    SELENIUM SULFIDE  ONE PERCENT
  • PURPOSE

    ANTI DANDRUFF
  • USES

    For relief of flaking, and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of reoccurence
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    ASK A DOCTOR BEFORE USING IF YOU HAVE

    SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.  FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    SHAKE WELL, APPLY A SHAMPOO, RINSE THOROUGHLY.  FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

  • INACTIVE INGREDIENTS

    WATER, AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, ACRYLATES COPOLYMER, AMMONIUM XYLENESULFONATE, FRAGRANCE, DIMETHICONE, CETYL ALCOHOL, SODIUM BENZOATE, CITRIC ACID, SODIUM HYDROXIDE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, SODIUM CITRATE, RED 4 (CI 14700).

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    HEB DANDRUFF  
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-613
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CARBOMER 934 (UNII: Z135WT9208)  
    3-HYDROXY-4-METHOXYBENZENESULFONIC ACID (UNII: 05L0075KBX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-613-14420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/08/2011
    Labeler - H E B (007924756)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture
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