Label: SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL- pyrithione zinc shampoo, suspension

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

Drug Label Information

Updated October 21, 2023

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  • Drug Facts

  • Active Ingredient

    Pyrithione Zinc, 1%

    Purpose

    Antidandruff

  • Use

    Controls scalp itching an flaking due to 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

    avoid contact with 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 help or call a Poison Control Center right away.

  • Directions

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

    Water, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Laureth Sulfate, Cocamidopropyl Betaine, PEG-3 Glyceryl Cocoate, Hydroxypropyl Methylcellulose, Sodium Cocoamphopropionate, Glycol Distearate, Glycol Stearate, Glycol, Magnesium Aluminum Silicate, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Triethylene Glycol, Magnesium Nitrate, Copper Sulfate, Citric Acid, Fragrance, Blue 1

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL 
    pyrithione zinc shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-036
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-036-00280 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/01/2020
    Labeler - J. Strickland and Co. (007023112)
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