Label: 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 January 12, 2023

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  • Active ingredient

    Selenium sulfide 1%

  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Use

    helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis

  • Warnings

    For external use only

  • Ask a doctor before use if

    condition covers a large area of the body

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if 

    • condition worsens or does not improve after regular use as directed
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • for maximum dandruff control, use every time you shampoo
    • wet hair, massage onto scalp, rinse, repeat if desired
    • for best results use at least twice a week or as directed by a doctor
    • if used on bleached, gray, tinted or permed hair, rinse for at least 5 minutes
  • Inactive ingredients

    water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, amodimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydrogen peroxide, hydroxypropyl methylcellulose, methylchlorisothiazolinone, methylisothiazolinone, red 4

  • Questions or comments?

    1-800-593-0593

  • SPL UNCLASSIFIED SECTION

    Intensive treatment

    100% GUARANTEE promise   If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.   You have our word on it.

    MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

  • principal display panel

    H-E-B DANDRUFF SHAMPOO

    With Selenium Sulfide

    INTENSIVE TREATMENT

    MAXIMUM STRENGTH

    RELIEVES DRY SCALP AND ITCH

    Leaves Hair Healthy Looking & Fights Dry Scalp

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-816
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-816-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/25/2016
    Labeler - HEB (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-816)
    Establishment
    NameAddressID/FEIBusiness Operations
    RWM TECHNOLOGIES LLC626626969manufacture(37808-816)
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