DANDRUFF (PYRITHIONE ZINC) SHAMPOO [MALIN AND GOETZ INC]

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [MALIN AND GOETZ INC]
PDF | XML

NDC 53634-127-01
Set ID 1eeaee85-e231-4b49-b643-c1d1aabf8642
Category HUMAN OTC DRUG LABEL
Packager Malin and Goetz Inc
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Active ingredient              Purpose

    Pyrithizone Zinc 1.9%      Anti-Dandruff

  • PURPOSE

    Uses Controls the symptoms of:

    • dandruff 
    • seborrheic dermatitis
  • 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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if

    too much skin irritation or sensitivity develops and increases

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

  • DOSAGE & ADMINISTRATION

    Directions

    • for best results, use at least twice a week or as directed by a doctor
    • Wet hair thoroughly, pour into palm; rub hands together to form a rich lather and massage into scalp
    • Rinse thoroughly
    • repeat if desired
  • INACTIVE INGREDIENT

    Water (aqua), Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Acrylates/C1-30 Alkyl Acrylate Crosspolymer, Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium Hydroxide, Glycerin, Disodium EDTA, Eucalyptus Globulus Leaf Extract, Limonene, Panthenol, Betaine, Hydrolyzed Wheat Starch, Serine, Glutamic Acid, Glycine, Lysine, Alanine, Arginine, Threonine

  • PRINCIPAL DISPLAY PANEL

    (Malin+Goetz)

    Dandruff Shampoo

    8fl.oz. 236ml

    Bottle

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BETAINE (UNII: 3SCV180C9W)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SORBITOL (UNII: 506T60A25R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    LYSINE (UNII: K3Z4F929H6)  
    ALANINE (UNII: OF5P57N2ZX)  
    ARGININE (UNII: 94ZLA3W45F)  
    THREONINE (UNII: 2ZD004190S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53634-127-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/04/2017
    Labeler - Malin and Goetz Inc (138615930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Milbar Laboratories, Inc.195556790manufacture(53634-127)

Related Drugs