Label: FEIX BIOAZUFRE / BIOSULPHUR- sulfur soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 25, 2012

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  • ACTIVE INGREDIENT

    Feix solid soap, made with coconut fatty esters and sulfur bio-fluid for washing oily skin,or acne-like hyper-secretory.
  • PURPOSE

    Feix solid soap is ideal for washing the skin with rashes, or very sensitive to alkali and soaps made with high concentrations of lye (caustic soda).
  • KEEP OUT OF REACH OF CHILDREN

    This product must be keep out reach of the children.
  • INDICATIONS & USAGE

    This product is indicated for people who have hypersecretion of fat in the skin. It is used as a regular soap bar with the variety that this soap removes impurities from skin oils.

  • WARNINGS

    Feix, does not irritate or dry skin, is well tolerated at any age.

  • DOSAGE & ADMINISTRATION

    Feix biosuphur is topical application, rub the soap on the area to be treated gently massaging foam is generated.
  • INACTIVE INGREDIENT

    This soap is made from a series of the ester type excipients that allow proper formation of soap, besides having ingredients that provide moisture to the skin.
  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE CARTON LABEL
    IMAGE OF THE CARTON LABEL
  • INGREDIENTS AND APPEARANCE
    FEIX  BIOAZUFRE / BIOSULPHUR
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM SARCOSINATE (UNII: 6EHN3PQL8Z)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPYRITHIONE (UNII: 9L87N86R9A)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (BEIGE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-002-0170 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358H05/01/2006
    Labeler - SPAI-SONS PHAMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COMSETICS880172184analysis, label, manufacture, pack