Label: FORTE MAGNETIC S3 OIL CONTROL ANTI-DANDFUFF- piroctone olamine lotion/shampoo

  • NDC Code(s): 84655-101-01, 84655-101-02
  • Packager: FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 13, 2024

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

  • ACTIVE INGREDIENT

    Active ingredient: Piroctone Olamine 0.4g/500g

  • PURPOSE

  • INDICATIONS & USAGE

    Uses: Helps prevent recurence of flaking and itching associated with dandruff

  • WARNINGS

  • WHEN USING

    When using this product:
    Avoid contact with eyes.If contact occurs,rinse eyes thoroughly with water.
    If accidentally ingested,please seek medical treatment.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose,get medical help or contaet a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:
    For best results use at least twice a week or as directed by a doctor.
    Wet your hair,and gently massage the scap and roots with an appropriate amount of shampoo,based on your hair quantity.Rinse with
    clean water

  • OTHER SAFETY INFORMATION

    Other information:
    Store at 5-30C;
    Keep out of direct sunlight;
    This product contains plant-derived ingredients.Their odor and color may change with temperature and humidity; these changes are nomal;
    This product has no magnetic properties, but the ingredients are based on the interaction of opposite charges attracting.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water (Aqua), Sodium lauroyl Methyl Isethionate, Disodium Laureth Sulfosuccinate, Sodium C14-16 Olefin Sulfonate, Potassium Cocoyl Glycinate, Polysorbate 20, Propylene Glycol, Potassium Cocoate, Cocamidopropyl Betaine, Fragrance, Trisodium Ethylenediamine Disuccinate, Betaine, Ceteareth-60 Myristyl Glycol, Cetrimonium Chloride, Hydroxyacetophenone, Isopropyl Alcohol, Phenoxyethanol, Sodium Lauraminopropionate, Polyquaternium-10, Sodium Chloride, Hexylene Glycol, Caprylhydroxamic Acid, Capryloyl Glycine, Butylene Glycol, Polyquaternium-55, Xylitylglucoside, Glycerin, Sodium Acetate, Enantia Chlorantha Bark Extract, Caprylyl Glycol, Creatine, Glycolic Acid, Polyglyceryl-10 Laurate, Polyquaternium-7, Oleanolic Acid, Sodium Citrate, Sodium Benzoate, Citric Acid, Isostearic Acid

  • QUESTIONS

    Questions?

    Dist.By Formosa Biomedical Technology Corporation
    formmosabio@fpg.com.tw

  • PRINCIPAL DISPLAY PANEL

    FORTE Magnetic S3 Oil Control Anti-Dandruff Shampoo

  • INGREDIENTS AND APPEARANCE
    FORTE MAGNETIC S3 OIL CONTROL ANTI-DANDFUFF 
    piroctone olamine lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84655-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB) (PIROCTONE - UNII:R49EFA73Q7) PIROCTONE OLAMINE0.4 g  in 500 g
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
    POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CREATINE (UNII: MU72812GK0)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYQUATERNIUM-55 (UNII: NG3KW6CD2J)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    BETAINE (UNII: 3SCV180C9W)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARETH-60 MYRISTYL GLYCOL (UNII: 4O832ZOY6W)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM LAURAMINOPROPIONATE (UNII: X5NJA9HXPU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84655-101-021 in 1 BOX08/13/2024
    1NDC:84655-101-01500 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/13/2024
    Labeler - FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION (658521104)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION658521104manufacture(84655-101)