Label: BLUE CAP- zinc pyrithione shampoo

  • Category: HUMAN OTC DRUG LABEL

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 September 13, 2018

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  • ACTIVE INGREDIENTS PURPOSE

    Pyrithione Zinc 1%.................. Anti dandruff/ Seborrheic Dermatitis

    Bottle

  • Warnings

    • For external use only.
    • Avoid contact with the eyes. If contact occurs rinse the eyes throughly with water
    • If conditions worsens or does not improves after regular use of this product as directed, consult with a doctor
    • When using this product
    • KEEP out of the reach of children. In case of overdose get medical help or contact the Poison Control Center inmediately.

    WARNINGS

    • For external use only.
    • Avoid contact with the eyes. If contact occurs rinse the eyes throughly with water
    • If conditions worsens or does not improves after regular use of this product as directed, consult with a doctor
    • When using this product
    • KEEP out of the reach of children. In case of overdose get medical help or contact the Poison Control Center inmediately.

    Warnings

    Keep out of reach of children

  • Questions or comments?

    + 34 91 345 6902 M-F 9:00 am to 5:00 pm

  • Other Information

    . keep the product in a cool and dry place

  • Directions

    • Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water.
    • For best results use at least twice a week or as directed by the doctor

    • Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water.
    • For best results use at least twice a week or as directed by the doctor
  • Uses

    • For the relief of the symptons of dandruff and seborrheic dermatitis

  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Zinc Pyrithione, Alcohol Denat, Sodium Chloride, Menthol, Glycol Distearate, PEG/PPG-20/6 Dimethicone, Tocopheryl Acetate, Sodium Hydroxide, Steareth-4, Sodium Lauroyl Lactylate, Disodium EDTA, Propylene Glycol, Phenoxyethanol, Ceramide 3, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Carbomer, Xanthan Gum, Ethylhexylglycerin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Diazolidinyl Urea, Sodium Benzoate, Potassium Sorbate, Methylchloroisothiazolinone, Methylisothiazolinone, Methylparaben, Propylparaben, Triisopropanolamine, Hexyl Cinnamal, Limonene, Benzyl Salicylate

  • Uses

    • For the relief of the symptons of dandruff and seborrheic dermatitis
  • Package Label

    Box

  • INGREDIENTS AND APPEARANCE
    BLUE CAP 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARETH-4 (UNII: 1VBG09S3UL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64539-020-021 in 1 BOX07/30/2018
    1NDC:64539-020-01150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/30/2018
    Labeler - Catalysis, SL (862795119)
    Registrant - Catalysis, SL (862795119)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalysis, SL862795119manufacture(64539-020)
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