Label: 13.5OZ 2 IN 1 DANDRUFF HAIR CLEANSE AND CONDITIONER - SHEA AND COCOA BUTTER- pyrithione zinc shampoo shampoo

  • NDC Code(s): 58503-211-01
  • Packager: China Ningbo Shangge Cosmetics Technology Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 21, 2025

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  • Active ingredient

    Pyrithione Zinc 0.5%

  • Purpose

    Anti-dandruff

  • Use


    Helps prevent recurrence of flaking and itching associsted with dandruff.

  • Warnings


    For external use only

  • When using this product


    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if


    Condition worsens or does not improve after regular use of this products as directed.

  • Keep out of reach of children


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

  • Directions

    Wet hair, massage onto scalp, rinse. Repeat if desired. For best resultd use at least twice a week or as directed by a doctor

  • Other information

    Store at room temperature.

  • Inactive ingredients


    Water
    Sodium Laureth Sulfate
    Cocamidopropyl Betaine
    Sodium Chloride
    Cocamide MEA
    Fragrance
    Gellan Gum
    Citric Acid
    Zinc Chloride
    Calcium Chloride
    Glycerin
    Disodium EDTA
    Aloe Barbadensis Leaf Extract
    Methylchloroisothiazolinone
    Methylisothiazolinone
    Yellow 5
    Blue 1

  • PRINCIPAL DISPLAY PANEL

    JPG

  • INGREDIENTS AND APPEARANCE
    13.5OZ 2 IN 1 DANDRUFF HAIR CLEANSE AND CONDITIONER - SHEA AND COCOA BUTTER 
    pyrithione zinc shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDE MEA (UNII: C80684146D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    RED 33 (UNII: 9DBA0SBB0L)  
    ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
    YELLOW 5 (UNII: I753WB2F1M)  
    GELLAN GUM (UNII: 7593U09I4D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-211-01400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/17/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/17/2025
    Labeler - China Ningbo Shangge Cosmetics Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetics Technology Corp.529287434manufacture(58503-211)
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