Label: DR.FORHAIR FOLLIGEN- pyrithione zinc 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 7, 2019

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

  • ACTIVE INGREDIENT

    zinc pyrithione 0.288%

    Salicylic Acid 0.2%

  • INACTIVE INGREDIENT

    Water, Disodium Laureth Sulfosuccinate, Lauryl hydroxy sultaine, Cocamide Methyl MEA, Styrene/Acrylates Copolymer, Glycerin, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Propanediol, Fragrance, Sodium Lauroyl Methylaminopropionate, Alcohol, PEG-45 Palm Kernel Glycerides, Panthenol, C12-13 Alkyl Lactate, Polyquaternium-10, Cetrimonium Chloride, Menthol, Cocamidopropyl Betaine, Caprylyl Glycol, Trihydroxystearin, Disodium EDTA, Zinc Chloride, Sodium benzoate, Polyquaternium-7, PEG-6 Caprylic/Capric Glyceride , Ethylhexylglycerin, Sodium Chloride, Citric Acid, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Adenosine, Disodium Phosphate , Niacinamide, Moringa Oleifera Seed Oil, Tocopherol, Biotin, Ceramide NP, Lecithin, Caprylic/Capric Triglyceride, Polysorbate 80, Serenoa Serrulata Fruit Extract, Caffeic Acid, Rhodiola Rosea Root Extract, Dioscorea Japonica Root Extract, Paeonia Lactiflora Root Extract, Zingiber Officinale (Ginger) Root Extract, Sophora Flavescens Extract, 1,2-Hexanediol

  • PURPOSE

    Antidandruff

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    Helps prevent recurrence of flaking and itching associated with dandruff

  • WARNINGS

    For external use only.

    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.

  • DOSAGE & ADMINISTRATION

    Apply to wet hair. Work into a rich lather and gently massage into scalp and hair. Rinse thoroughly with lukewarm water.

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    DR.FORHAIR FOLLIGEN 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69244-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.88 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM LAUROYL METHYLAMINOPROPIONATE (UNII: 99E3R68Y9B)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-45 PALM KERNEL GLYCERIDES (UNII: UC117W498W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69244-0007-21 in 1 CARTON08/06/2019
    1NDC:69244-0007-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/06/2019
    Labeler - Humajor Co., Ltd. (689061827)
    Registrant - Humajor Co., Ltd. (689061827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmocos Co., Ltd689387376manufacture(69244-0007)