Label: ZINC PYRITHIONE shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 2, 2019

If you are a consumer or patient please visit this version.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contact Poison Control Center Right Away

  • PURPOSE

    Anti-Dandruff

  • WARNINGS

    For external use only. When using this product avoid contact with eyes.

  • INDICATIONS & USAGE

    • Helps control the symptoms of scalp itch and Dandruff symptoms associated with minor skin irritations and rashes due to:
    • Seborrheic Dermatitis
  • ACTIVE INGREDIENT

    Zinc Pyrithione 1%

  • DOSAGE & ADMINISTRATION

    After cleansing hair and scalp with Step 1 Dr. Marder Scalp Therapy Total Relief Shampoo, apply to clean, wet hair. Massage into hair and scalp, concentrating on scalp and ends. Rinse thoroughly. Repeat. Use Daily if needed.

  • INACTIVE INGREDIENT

    CAMELLIA SINENSIS SEED OIL

    GLYCERIN

    GUAR GUM

    HUMULUS LUPULUS STEM

    AMINO ACIDS, SILK

    BEHENTRIMONIUM METHOSULFATE

    PANTHENOL

    AMINO ACIDS, HAIR KERATIN

    CORN

    ARGANIA SPINOSA LEAF

    PHENOXYETHANOL

    SAW PALMETTO

    SIMMONDSIA CHINENSIS LEAF

    SORBITAN OLIVATE

    SHEA BUTTER

    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE

    CETEARYL OLIVATE

    COCONUT OIL

    ETHYLHEXYLGLYCERIN

    ALOE VERA LEAF

    WATER

    CETOSTEARYL ALCOHOL

    EQUISETUM ARVENSE BRANCH

  • PRINCIPAL DISPLAY PANEL

    Principal Display panel

  • INGREDIENTS AND APPEARANCE
    ZINC PYRITHIONE 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71516-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAR GUM (UNII: E89I1637KE)  
    HUMULUS LUPULUS STEM (UNII: OU3SJO07MD)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
    CORN (UNII: 0N8672707O)  
    ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71516-002-01180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/14/2017
    Labeler - Dr Marder Skincare LLC (146890103)