Label: SULFUR 8 FIVE STAR ANTI-DANDRUFF HAIR GROOM- pyrithione zinc cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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  • Active Ingredients

    Pyrithione Zinc, 0.1%

    Purpose

    Anti-dandruff

  • Use:

    Controls scalp itching and flaking due to 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 consult a doctor if 

    • condition worsens or does not improve after regular use.

    Keep out of reach of children

    If swallowed, get medical helpor call a poison contril center at once.

  • Directions

    • Apply to the affected area 1-4 times daily, or as dircted by a doctor.
  • Inactive Ingredients

    Water, Petrolatum, Mineral Oil, Glycerin, Ricinis Communis (Castor) Seed Oil, Stearyl Alcohol, Behentrimonium Methosulfate, Beeswax (Cera Alba), Dimethicone, Lanolin, Oleth-20, Polyquaterinium-11, Allantoin, Panthenol, Propylene Glycol, Butylene Glycol, Cetyl Alcohol, Sorbitan Trioleate, Diazolidinyl Urea, Methylparaben, Sodium Sulfate, Propylparaben, Fragrance (Parfum). 

  • Package Labeling

    12022-030-00

  • INGREDIENTS AND APPEARANCE
    SULFUR 8 FIVE STAR ANTI-DANDRUFF HAIR GROOM 
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LANOLIN (UNII: 7EV65EAW6H)  
    OLETH-20 (UNII: YTH167I2AG)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-030-0099 g in 1 TUBE; Type 0: Not a Combination Product04/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03204/29/2010
    Labeler - J. Strickland & Co. (007023112)
    Registrant - J. Strickland & Co. (007023112)
    Establishment
    NameAddressID/FEIBusiness Operations
    J. Strickland & Co.007023112manufacture(12022-030)
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