Label: DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 74553-003-01
  • Packager: Xtreme Tools International, Inc
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 15, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Pyrithione zinc 2%

  • Purpose

    Anti-dandruff

  • Use

    Helps prevent itching and flaking associated with dandruff.

  • Warning

    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 product.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help, or contact a Poison Control Center right away.

  • Directions

    • shake well
    • For best results use at least twice a week or as directed by a doctor
  • Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide MEA, Glycol Distearate, Polysorbate 20,PPG-10 Cetyl Ether, PEG-8, Polyquaternium-10, Acrylates, Vinyl Neodecanoate, Crosspolymer, Hydrolyzed Wheat Protein, Ricinus Communis (Castor) Seed Oil, Hydrolyzed Keratin, Chitosan Succinamide, Argania Spinosa (Argan) Kemel Oil, Olea Europaea (Olive) Oil, Sodium Benzoate, Pottassium Sorbate, Fragrance, Citric Acid, CI 42090

  • Questions or comments?

    Call 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM

  • PACKAGE LABEL

    473 mL in Bottle; NDC 74553-003-01

    SHAMPOO

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PPG-10 CETYL ETHER (UNII: Q056X4917J)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN (1000 MW) (UNII: 8V0I3U3HMO)  
    POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    VINYL NEODECANOATE (UNII: 9NDY01YYPT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CHITOSAN SUCCINAMIDE (1300 MPA.S) (UNII: 41164V2SNS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-003-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/06/2020
    Labeler - Xtreme Tools International, Inc (125398904)
    Registrant - Xtreme Tools International, Inc (125398904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xtreme Tools International, Inc125398904manufacture(74553-003)