Label: MENS SPORT- pyrithione zinc shampoo

  • NDC Code(s): 63148-208-20
  • Packager: Apollo Health and Beauty Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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

  • Active Ingredients

    Pyrithione Zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    Helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For External use only.

    When using the Product

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

    Stop use and ask a doctor if

    condition worserns or does not improve after regular use of this product as directed.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply a generous amount to wet hair, massage onto scalp and work evenly to the ends.
    • Leave on for 3-5 minutes.
    • Rinse throughly.
    • For best results use at least twice a week or as directed by a doctor.
  • Inactive Ingredients

    Acrylates Copolymer, Blue 1 (CI 42090), Cocamide MEA, Cocamidopropyl Betaine, Dimethicone, Fragrance, Glycol Distearate, Guar Hydroxypropyltrimonium Chloride, Laureth-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tetrasodium EDTA, water, Zinc Chloride.

  • Principal Display Panel

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    MENS SPORT 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1000 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    RED 33 (UNII: 9DBA0SBB0L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TETRASODIUM EDTA (UNII: MP1J8420LU)  
    DIRECT BLUE 1 (UNII: 8NN34MAQ6H)  
    COCAMIDE MEA (UNII: C80684146D)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    LAURETH-4 (UNII: 6HQ855798J)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-208-20612 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03211/01/2024
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-208)