Label: SULFUR 8 AQUA BLUE- pyrithione zinc shampoo, suspension

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

Drug Label Information

Updated October 21, 2023

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  • Active Ingredients

    Pyrithione Zinc, 1%

    Purpose

    Antidandruff

  • Use:

    relieves scalp itching, irritation, redness, scaling and flaking associated with dandruff

  • Warnings:

    For external use only

    Ask a doctor before use if you have

    • seborrheic dermatitis that covers a large area of the body.

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and consult a doctor if

    • conditions worsens or does not improve after regular use.

    Keep out of reach of children

    If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    • shake well
    • for best results, use twice a week 
    • wet hair, apply shampoo, lather, rinse & repeat
  • Inactive Ingredients

    SD Alcohol 40, Water, Propylene Glycol, Benzyl Alcohol, Menthol.

  • Package Labeling

    12022-024-00

  • INGREDIENTS AND APPEARANCE
    SULFUR 8 AQUA BLUE 
    pyrithione zinc shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-024-00222 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03207/15/2002
    Labeler - J. Strickland & Co. (007023112)
    Registrant - J. Strickland & Co. (007023112)
    Establishment
    NameAddressID/FEIBusiness Operations
    J. Strickland & Co.007023112manufacture(12022-024)