Label: SPAI-SONS ACID ANTI-DANDRUFF- sulfur 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 June 6, 2012

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  • ACTIVE INGREDIENT

    This formula includes Biosulfur fluid, that is highest effectiveness for the scalp.

  • PURPOSE

    This fromula includes the active ingredient containing the highest effectiveness for the scalp called greasy dandruff

  • KEEP OUT OF REACH OF CHILDREN

    This product must be keep out reach of children

  • INDICATIONS & USAGE

    This product is for topical application. Wash the hair with the shampoo in the shower

  • WARNINGS

    If this product is contact with eyes rinse immediately with water and consult your doctor.

  • DOSAGE & ADMINISTRATION

    To wash daily during 8 or 10 weeks, soon interdaily use until the remission of the problem. The product is for topical application.

  • INACTIVE INGREDIENT

    Its components make it tolerable for daily use or washing the scalp affected

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SPAI-SONS  ACID ANTI-DANDRUFF
    sulfur shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAURETH-10 (UNII: BD7AST04GA)  
    DIPYRITHIONE (UNII: 9L87N86R9A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-021-01210 mL in 1 BOTTLE
    2NDC:66854-021-02250 mL in 1 BOTTLE
    3NDC:66854-021-03250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/30/2012
    Labeler - SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack
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