Label: BLUE CAP- zinc pyrithione spray

  • 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 September 13, 2018

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  • ACTIVE INGREDIENTS PURPOSE

    Pyrithione Zinc 0.19%.................. Antidandruff/ Seborrheic Dermatitis

    Tube

  • Warnings

    • For external use only.
    • Avoid contact with the eyes. If contact occurs, rinse throughly with water
    • If conditions worsens or does not improve 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 a Poison Center inmediately

    WARNINGS

    • For external use only.
    • Avoid contact with the eyes. If contact occurs, rinse throughly with water
    • If conditions worsens or does not improve 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 a Poison 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

    • Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area.
    • For best results use at least twice a week or as directed by the doctor

    • Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area.
    • 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

    Isopropyl Myristate, Alcohol, Isobutane, Propane. Bisabolol, Polysorbate 80, Zinc Pyrithione, Butane, Tocopheryl Acetate, Farnesol

  • Uses

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

    Box

  • INGREDIENTS AND APPEARANCE
    BLUE CAP 
    zinc pyrithione spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.19 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FARNESOL (UNII: EB41QIU6JL)  
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTANE (UNII: 6LV4FOR43R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64539-021-021 in 1 BOX07/31/2018
    1NDC:64539-021-01100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/31/2018
    Labeler - Catalysis, SL (862795119)
    Registrant - Catalysis, SL (862795119)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalysis, SL862795119manufacture(64539-021)
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